Senes apteo med
Poland
Table of Contents
Package leaflet: Information for the patient
SENES APTEO MED
28 mg sennosides/pouch, herbal tea in tea bags
Sennae foliolum + Sennae fructus angustifoliae
Please read the entire leaflet carefully 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
physician, pharmacist, or nurse.
- 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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement after 2-3 days, or if you feel worse, contact your doctor.
Table of contents of the leaflet
- What Senes Apteo Med is and what it is used for
- Important information before taking Senes Apteo Med
- How to take Senes Apteo Med
- Possible side effects
- How to store Senes Apteo Med
- Contents of the pack and other information
1. What Senes Apteo Med is and what it is used for
This is a laxative medicine intended for oral use in the form of an infusion to drink.
The medicinal product is intended for short-term treatment of constipation.
This herbal medicinal product has traditionally been used in the indications listed, based solely on long-standing use.
2. Information before using Senes APTEO MED
When not to use Senes APTEO MED
- If the patient is allergic to the active substances,
- In acute or chronic, undiagnosed abdominal disorders,
- In cases of intestinal obstruction or narrowing of the intestines,
- In inflammatory conditions of the large intestine (e.g. ulcerative colitis, Crohn's disease), or appendicitis,
- In severe dehydration and electrolyte loss.
Warnings and precautions
Before starting treatment with Senes APTEO MED, discuss this with your doctor,
pharmacist, or nurse.
Chronic use may worsen constipation symptoms due to weakened intestinal peristalsis.
It is not recommended to use this product for longer than 7–10 days. Use only when dietary changes
or mild laxatives (bulking agents) do not provide the desired effect.
If no laxative effect occurs within 2–3 days, consult your doctor.
Overdosing may lead to electrolyte loss along with diarrhea, potentially causing fluid and electrolyte imbalances, including reduced potassium levels, which may result in cardiac and muscular disturbances.
Long-term use may cause proteinuria and hematuria, as well as deposition of pigments in the intestinal mucosa, which is harmless and usually reversible.
Children
Due to lack of available data, use of this medicine is not recommended in children under 12 years of age.
Senes APTEO MED and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Concomitant use with other medicines that reduce potassium levels (e.g. thiazide diuretics, corticosteroids, and liquorice root) may intensify electrolyte imbalance.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Use during pregnancy is not recommended. Use during breastfeeding is not recommended.
Driving and operating machinery
Senes APTEO MED has no influence on the ability to drive or operate machinery.
3. How to use Senes APTEO MED
This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
If you feel that the effect of Senes APTEO MED is too strong or too weak, further use of the medicine should be discussed with your doctor.
Dosage
Oral administration.
Adults and adolescents over 12 years of age:
Pour one sachet with a glass of boiling water, cover and let stand for 10 minutes. Drink the warm infusion in the evening, before bedtime. The laxative effect usually occurs 6–10 hours after taking the medicine. It is recommended to consume 1/2 or 2/3 of a glass of the infusion to achieve the therapeutic effect. The maximum dose, which is one glass of infusion prepared from one sachet, should not be exceeded. Prolonged use of the product for more than 7–10 days is not recommended.
Use in children
Due to lack of available data, use in children under 12 years of age is not recommended.
Taking more Senes APTEO MED than recommended
Symptoms of overdose include abdominal cramps and acute diarrhoea leading to loss of water and electrolytes.
Missing a dose of Senes APTEO MED
Do not take a double dose to make up for a missed dose.
Stopping Senes APTEO MED
If you have any doubts concerning the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions of this medicine are presented according to organ systems classification as per MedDRA and frequency of occurrence: frequency unknown (cannot be estimated based on available data).
Gastrointestinal disorders: frequency unknown (disorders may occur particularly in patients with hypersensitive colon):
- abdominal cramps,
- abdominal pain.
Renal and urinary disorders: frequency unknown (urine discoloration caused by anthranoid metabolites – no clinical significance):
- yellow discoloration of urine,
- red-brown discoloration of urine.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Senes APTEO MED
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: "Expiry date". The expiry date refers to the last day of the specified month.
Store at a temperature not exceeding 25°C, in dry and well-ventilated areas.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the packaging and other information
What Senes APTEO MED contains
The active substances in Senes APTEO MED are leaf of senna (Sennae foliolum) and fruit of senna (Sennae fructus angustifoliae).
What Senes APTEO MED looks like and contents of the pack
Senes APTEO MED is a medicine in the form of heat-sealable paper sachets for single-dose infusion.
The medicine is available in packaging containing 30 sachets of 1.1 g each.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
tel.: 22 32 16 240
Manufacturer
ELANDA PHARMA Sp. z o.o.
ul. Sportowa 9
97-340 Rozprza