Senalax Extra

Leaflet included in the packaging: patient information

SENALAX EXTRA

17 mg of total sennosides, coated tablets
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as advised by
your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Senalax Extra and what is it used for
• 2. Important information before using Senalax Extra
• 3. How to use Senalax Extra
• 4. Possible side effects
• 5. How to store Senalax Extra
• 6. Package contents and other information

1. What is Senalax Extra and what is it used for

The medicine has a laxative effect.
The active substances of Senalax Extra, sennosides, affect the motor activity of the large intestine,
leading to accelerated movement of fecal masses. Additionally, they stimulate the secretion of mucus and
chlorides, which leads to increased secretion of water and electrolytes into the intestinal lumen and causes
softening of the stool.

Indications for use

Senalax Extra is used for the treatment of constipation.

2. Important information before using Senalax Extra

When not to use Senalax Extra:

Senalax Extra should not be used in the case of:

• hypersensitivity to the active substance or any of the other ingredients of this medicine (listed in section 6),
• intestinal obstruction or narrowing, intestinal atony (intestinal paralysis),
• inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis),
• appendicitis,
• abdominal pain of unknown cause,
• dehydration with accompanying electrolyte imbalance,
• children under 12 years of age.

Warnings and precautions

Before starting to use Senalax Extra, you should discuss it with your doctor, pharmacist, or nurse.
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The medicine should not be used for longer than 1-2 weeks.
If symptoms of constipation persist during the use of the medicine, you should consult your doctor or pharmacist.
Patients taking cardiac glycosides, antiarrhythmic drugs, drugs that prolong the QT interval, diuretics, glucocorticosteroids, or licorice root products should consult their doctor before using the medicine.
Like other laxatives, Senalax Extra should not be used without medical consultation by patients who experience symptoms of intestinal obstruction, such as fecal impaction, absence of bowel movements, abdominal pain, nausea, vomiting.
You should avoid prolonged use of laxatives.
Chronic, longer-than-recommended use of the medicine may worsen constipation symptoms due to weakened intestinal peristalsis, as well as lead to dependence on laxatives.
The medicine should be used with caution in patients with renal failure due to the risk of electrolyte imbalance.
The medicine should only be used when dietary changes and subsequent use of mild laxatives (bulk-forming) have not produced the desired effects.

Children

The medicine should not be used in children under 12 years of age.

Senalax Extra and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
The medicine may reduce the absorption of other orally administered medicines (including oral contraceptives).
Prolonged use may lead to hypokalemia (decreased potassium levels in the blood), which can increase the effects of cardiac glycosides, antiarrhythmic drugs (e.g., quinidine), and drugs that prolong the QT interval.
Concomitant use of the medicine with products that cause sodium or potassium loss (e.g., diuretics, glucocorticosteroids, or licorice root products) may lead to electrolyte imbalance.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Use of the medicine during pregnancy and breastfeeding is not recommended.

Driving and using machines

Senalax Extra does not affect the ability to drive or use machines.

Senalax Extra contains aluminum lake of sunset yellow FCF (E110) and aluminum lake of quinoline yellow (E104)

Senalax Extra may cause allergic reactions due to the presence of dyes – aluminum lake of quinoline yellow (E104) and aluminum lake of sunset yellow FCF (E110).
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3. How to use Senalax Extra

This medicine should always be used exactly as described in the patient leaflet or as advised by
your doctor, pharmacist, or nurse. In case of doubt, you should consult your doctor, pharmacist, or nurse.
Oral administration.
Adults and adolescents over 12 years:1 tablet at night. The medicine is usually used 2 to 3 times a week for 1 to 2 weeks.
Use of the medicine for longer than 1-2 weeks requires medical supervision.
The laxative effect occurs within 8 to 12 hours after taking the medicine.
The medicine should not be used more frequently than once a day. You should not exceed the recommended dose.

Using a higher dose of Senalax Extra than recommended

In case of taking a higher dose than recommended, the following may occur: spasmodic abdominal pain and severe diarrhea, resulting in water and electrolyte loss (especially potassium and calcium), which can lead to cardiac arrhythmias, as well as weakness, dizziness, and painful muscle cramps. These symptoms may worsen during concomitant use of cardiac glycosides, diuretics, glucocorticosteroids, or licorice root products.
Chronic use of higher-than-recommended doses may lead to toxic liver inflammation.
In case of overdose, after discontinuing the medicine, you should replenish water and electrolyte deficiencies.
If you have taken a higher dose of the medicine than recommended, you should contact your doctor.

Missing a dose of Senalax Extra

This does not apply.
In case of any further doubts related to the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions, such as hives, itching, rash, may occur.
Abdominal cramps and liquid stools may occur. The above symptoms may also indicate an overdose of the medicine.
Chronic use of the medicine may lead to electrolyte imbalance, as well as proteinuria and hematuria. Additionally, chronic use may cause discoloration of the intestinal mucosa (pseudomelanosis coli), which usually resolves after discontinuing the medicine. Urine discoloration (to yellow or reddish-brown) may also occur.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw,
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tel. +48 22 49 21 301, fax: + 48 22 49 21 309,
e-mail: ndl@urpl.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Senalax Extra

Store in the original packaging, 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. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Senalax Extra contains

• The active substance of the medicine is calcium sennosides (Calcii sennosides) 60%. One tablet of the medicine contains 17 mg of total sennosides.
• The other ingredients (excipients) are: microcrystalline cellulose, silanized (microcrystalline cellulose, anhydrous colloidal silica), calcium hydrogen phosphate dihydrate, sodium carboxymethyl cellulose (type A), anhydrous colloidal silica, magnesium stearate, Opadry II 85F23368 Orange coating (polyvinyl alcohol (partially hydrolyzed), macrogol (PEG MW 3350), talc, aluminum lake of sunset yellow FCF (E110), titanium dioxide (E171), aluminum lake of quinoline yellow (E104)).

What Senalax Extra looks like and contents of the pack

Senalax Extra is orange, biconvex, smooth, uniform, intact, and odorless tablets.
One pack of the medicine contains 1 or 2 blisters of 15 coated tablets.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine Information
tel.
+48 (22) 742 00 22
email: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet:

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