Senalax extra
Poland
Table of Contents
Leaflet enclosed in the packaging: information for the patient
SENALAX EXTRA
17 mg of sennosides, coated tablets
Please read carefully the entire leaflet before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor, 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 side effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If your condition does not improve or if you feel worse, you should consult your doctor.
Contents of the leaflet:
- What Senalax Extra is and what it is used for
- Important information before taking Senalax Extra
- How to take Senalax Extra
- Possible side effects
- How to store Senalax Extra
- Contents of the package and other information
1. What Senalax Extra is and what it is used for
The medicine has a laxative effect.
The active substances in Senalax Extra—sennosides—affect the motor activity of the large intestine, resulting in accelerated movement of faecal matter. Additionally, they stimulate mucus and chloride secretion, leading to increased secretion of water and electrolytes into the intestinal lumen and causing softening of the stool.
Indications
Senalax Extra is used for the short-term treatment of constipation.
2. Information before using Senalax Extra
When not to use Senalax Extra:
Do not use Senalax Extra if you:
- are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
- have intestinal obstruction or intestinal atony (intestinal paralysis),
- suffer from inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis),
- have appendicitis,
- have abdominal pain of unknown cause,
- are dehydrated with accompanying loss of electrolytes,
- are under 12 years of age.
Warnings and precautions
Before starting to use Senalax Extra, consult your doctor, pharmacist, or nurse.
1/4
Do not use this medicine for longer than 1–2 weeks.
If constipation symptoms persist during treatment, consult your doctor or pharmacist.
Patients taking cardiac glycosides, antiarrhythmic drugs, drugs causing QT prolongation, diuretics, glucocorticosteroids, or liquorice root products should consult a doctor before using this medicine.
Like other laxatives, Senalax Extra should not be used without medical advice in patients presenting symptoms of intestinal obstruction such as faecal impaction, absence of flatus, abdominal pain, nausea, or vomiting.
Avoid prolonged use of laxative medicines.
Chronic, long-term use beyond the recommended duration may worsen constipation due to impaired intestinal peristalsis and may lead to dependence on laxatives.
Use with caution in patients with renal insufficiency due to the risk of electrolyte imbalance.
This medicine should only be used when dietary changes, followed by the use of mild laxatives (bulking agents), have not been effective.
Children
Do not use in children under 12 years of age.
Senalax Extra and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
This medicine may reduce the absorption of other orally administered medicines (including oral contraceptives).
During prolonged use beyond the recommended duration, hypokalaemia (low potassium levels in blood) may occur, which may increase the adverse effects of cardiac glycosides, antiarrhythmic drugs (e.g. quinidine), and drugs causing QT prolongation.
Concomitant use of this medicine with products causing loss of sodium or potassium (e.g. diuretics, glucocorticosteroids, or liquorice root products) may lead to electrolyte imbalance.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Use of this medicine during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
Senalax Extra has no influence on the ability to drive or operate machinery.
Senalax Extra contains aluminium lake of sunset yellow (E110) and aluminium lake of quinoline yellow (E104)
Senalax Extra may cause allergic reactions due to the presence of colouring agents – aluminium lake of quinoline yellow (E104) and aluminium lake of sunset yellow (E110).
2/4
3. How to use Senalax Extra
This medicine should always be taken exactly as described in the patient leaflet, or as advised by your doctor, pharmacist, or nurse. If you are unsure, consult your doctor, pharmacist, or nurse.
Oral use.
Adults and adolescents over 12 years of age: 1 tablet at night. The medicine is usually taken 2 to 3 times per week for 1 to 2 weeks.
Use of the medicine for longer than 1–2 weeks requires medical supervision.
The laxative effect occurs 8 to 12 hours after taking the medicine.
The medicine should not be used more frequently than once daily. Do not exceed the recommended dose.
Use of a higher than recommended dose of Senalax Extra
If a dose higher than recommended is taken, the following may occur: colicky abdominal pain and acute diarrhoea, leading to loss of water and electrolytes (especially potassium and calcium), which may result in cardiac rhythm disturbances, as well as weakness, tremors, and painful muscle cramps. These symptoms may be intensified when cardiac glycosides, diuretics, glucocorticosteroids, or liquorice root preparations are used concomitantly.
Chronic use of doses higher than recommended may lead to toxic liver inflammation.
In case of overdose, after discontinuation of the medicine, deficiencies in water and electrolytes should be corrected. If you have taken more than the recommended dose, contact your doctor.
Missed dose of Senalax Extra
Not applicable.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Hypersensitivity reactions may occur, such as itching, urticaria, and rash.
Cramp-like abdominal pain and diarrhoea may also occur. The above symptoms may also indicate drug overdose.
Chronic use of the medicine may lead to disturbances in water and electrolyte balance, as well as proteinuria and haematuria. Moreover, as a result of prolonged use, pigmentation of the intestinal mucosa (pseudomelanosis coli) may occur, which usually resolves after discontinuation of the medicine. A change in urine colour (to yellow or red-brown) may also appear.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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 181 C, 02-222 Warsaw,
3/4
tel. +48 22 49 21 301, fax: +48 22 49 21 309,
e-mail: [email protected].
Adverse effects can also be reported to the responsible entity.
By reporting adverse effects, more information on the safety of this medicine can be collected.
5. How to store Senalax Extra
Store in the original packaging, at a temperature below 25°C.
Keep the medicine out of the 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 specified month.
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 the medicine Senalax Extra contains
- The active substance in the medicine is calcium sennosides (Calcii sennosides) 60%. One tablet contains 17 mg of sennosides.
- The other ingredients (excipients) are: microcrystalline cellulose, colloidal silicon dioxide-containing microcrystalline cellulose (microcrystalline cellulose, anhydrous colloidal silicon dioxide), calcium hydrogen phosphate dihydrate, sodium carboxymethyl starch (type A), anhydrous colloidal silicon dioxide, magnesium stearate, Opadry II 85F23368 Orange coating (polyvinyl alcohol (partially hydrolysed), polyethylene glycol (PEG MW 3350), talc, orange yellow aluminium lake (E110), titanium dioxide (E171), quinoline yellow aluminium lake (E104)).
What Senalax Extra looks like and contents of the pack
Senalax Extra is an orange-coloured, biconvex tablet with a smooth, uniform surface, free from defects and odour. One pack contains 1 or 2 blisters with 15 coated tablets each.
Marketing Authorisation 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: [email protected]
4/4