Senes Apteo Med

Leaflet attached to the packaging: patient information

SENES APTEO MED

28 mg of sennosides per sachet, herbal infusion in sachets
Sennae foliolum + Sennae fructus angustifoliae

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 directed by a doctor or 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 the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 2-3 days, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Senes APTEO MED and what is it used for
• 2. Important information before using Senes APTEO MED
• 3. How to use Senes APTEO MED
• 4. Possible side effects
• 5. How to store Senes APTEO MED
• 6. Contents of the packaging and other information

1. What is Senes APTEO MED and what is it used for

This is a laxative medicine for internal use in the form of an infusion to drink.
The medicinal product is intended for short-term therapy of constipation.
The herbal medicinal product is used traditionally for the indications listed, resulting solely from its long-term use.

2. Important information before using Senes APTEO MED

When not to use Senes APTEO MED

• If the patient is allergic to the active substances,
• In cases of acute or chronic, undiagnosed abdominal complaints,
• In cases of intestinal obstruction and narrowing,
• In inflammatory conditions of the colon (e.g. ulcerative colitis, Crohn's disease), appendicitis,
• In conditions of severe dehydration and electrolyte loss.

Warnings and precautions

Before starting to use Senes APTEO MED, you should discuss it with your doctor or pharmacist, or nurse.
Chronic use may worsen constipation symptoms due to weakened intestinal peristalsis.
It is not recommended to use the product for more than 7-10 days. It should only be used when a change in diet or the use of mild laxatives (bulk-forming) does not produce the desired effects.
If there is no laxative effect within 2-3 days, you should contact your doctor.
Overdose of the product may cause, along with diarrhea, electrolyte loss, which can lead to water and electrolyte disorders, including a decrease in potassium levels, which can cause heart and muscle disorders.
Long-term use may cause proteinuria and hematuria, as well as the deposition of pigments in the intestinal mucosa, which is harmless and usually disappears.

Children

Due to the lack of available data, the use of the medicine in children under 12 years of age is not recommended.

Senes APTEO MED 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 take.
Concomitant use with other medicines that lower potassium levels (e.g. thiazide diuretics, corticosteroids, and licorice root) may exacerbate electrolyte balance disorders.

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.
It is not recommended to use during pregnancy. It is not recommended to use during breastfeeding.

Driving and using machines

Senes APTEO MED does not affect the ability to drive and use machines.

3. How to use Senes APTEO MED

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist, or nurse. If you are unsure, you should consult your doctor or pharmacist, or nurse.
If you feel that the effect of Senes APTEO MED is too strong or too weak, you should consult your doctor before taking the medicine further.
Dosage
Oral administration.
Adults and adolescents over 12 years old:
Pour one sachet with a glass of boiling water, leave for 10 minutes under cover. Drink the warm infusion in the evening, before bedtime. The laxative effect usually occurs after 6-10 hours of taking the medicine. It is recommended to take 1/2 or 2/3 of a glass of infusion to achieve a therapeutic effect. You should not exceed the maximum dose, which is a glass of infusion prepared from one sachet. It is not recommended to use the product for more than 7-10 days.

Use in children

Due to the lack of available data, the use of the medicine in children under 12 years of age is not recommended.

Using more than the recommended dose of Senes APTEO MED

Symptoms of overdose are abdominal cramps and severe diarrhea leading to decreased water and electrolyte levels.

Missing a dose of Senes APTEO MED

You should not take a double dose to make up for a missed dose.

Stopping the use of Senes APTEO MED

If you have any doubts about using this medicine, you should consult your doctor or pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects of the medicine are presented according to the classification of organs and systems according to MedDRA and frequency of occurrence: frequency not known (cannot be determined based on available data).
Gastrointestinal disorders: frequency not known (disorders may occur especially in patients with irritable bowel syndrome):

• abdominal cramps,
• abdominal pain. Renal and urinary disorders: frequency not known (urine discoloration caused by anthranoid metabolites - without clinical significance):
• yellow urine discoloration,
• red-brown urine discoloration.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should inform your doctor or pharmacist, or nurse. 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.: 22 49 21 301, fax: 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 Senes APTEO MED

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: "Expiry date". The expiry date refers to the last day of the given month.
Store in a temperature not exceeding 25°C, in dry and well-ventilated areas.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Senes APTEO MED contains

The active substances of the medicine are senna leaf ( Sennae foliolum) and senna fruit ( Sennae fructus
angustifoliae).

What Senes APTEO MED looks like and what the packaging contains

Senes APTEO MED is a medicine in the form of sachets with heat-sealable paper for single infusion.
The medicine is available in a packaging containing 30 sachets of 1.1 g each.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel.: 22 32 16 240

Manufacturer

ELANDA PHARMA Sp. z o.o.
ul. Sportowa 9
97-340 Rozprza

Date of the last update of the leaflet: