Active ingredients: Sennosides (sennosides A + B)
Pursennid 12 mg coated tablets
Why is Pursennid used? What is it for?
Pursennid contains the active substance of the Senna plant which belongs to a group of medicines that stimulate bowel movements.
Pursennid is indicated for the short-term treatment of occasional constipation. Pursennid works by stimulating bowel movements within 6-12 hours. For this reason it is preferable to take it in the evening.
Talk to your doctor if you don't feel better or if you feel worse after 7 days.
Contraindications When Pursennid should not be used
Do not take Pursennid
- if you are allergic to sennosides A + B or any of the other ingredients of this medicine
- if your doctor or pharmacist has told you not to take laxatives;
- if you have an inflammatory disease of the colon (for example Crohn's disease or ulcerative colitis);
- if you suffer from nausea, diarrhea, vomiting or stomach cramps;
- if you have acute, severe or persistent stomach pain or if your abdomen is soft to the touch and hurts when you move. In these cases, tell your doctor as you may have an undiagnosed bowel disease.
- if you have been diagnosed with severe dehydration with loss of water and salts (e.g. low potassium levels);
- if the patient is a child under the age of 10.
Precautions for use What you need to know before taking Pursennid
Talk to your doctor or pharmacist before taking Pursennid.
Persistent constipation must first be treated by eating a diet rich in fiber found for example in fruits, vegetables and cereals, by taking in a sufficient amount of fluids and by practicing physical activity.
Take special care and tell your doctor:
- if you have not seen any positive effects after taking Pursennid
- if you need to take the medicine for more than 7 days. Prolonged use can be addictive and can compromise bowel function.
- if symptoms continue or worsen while using Pursennid
- if you suffer from an inflammatory bowel disease
- if skin rashes, nausea or vomiting appear
- if you have recently undergone abdominal surgery
Children and adolescents
Pursennid should not be given to children under the age of 10. In children between the ages of 10 and 12, Pursennid can only be used under the supervision of a doctor.
Interactions Which drugs or foods may change the effect of Pursennid
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Tell your doctor if you are using:
- diuretics (medicines that increase urine production)
- adrecorticosteroids (hormonal medicines)
- digitalis and other medicines of the glycoside class (medicines used to treat heart problems)
- quinidine (medicines used to treat heart rhythm problems).
Pursennid with foods
- Do not take Pursennid with licorice root as it may alter the salt content in the body.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Pursennid during pregnancy unless your doctor tells you to.
Pregnancy
Do not take Pursennid while breastfeeding unless advised to by your doctor. Fertility Pursennid does not appear to have any particular risk to fertility when taken at therapeutic doses.
Driving and using machines
Pursennid does not affect the ability to drive or use machines.
Pursennid contains lactose, sucrose and glucose
This medicinal product contains lactose, sucrose and glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
Dose, Method and Time of Administration How to use Pursennid: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist
Take the smallest dose sufficient to produce easy evacuation of soft stools.
Take the minimum doses initially. You can then increase the dose if necessary but always be careful not to exceed the maximum recommended.
Do not exceed the recommended dose without first checking with your doctor.
Take Pursennid tablets whole with an adequate amount of water (a large glass) or other liquid. Remember that a diet rich in liquids promotes the effect of the medicine.
Take Pursennid preferably in the evening. The medicine will take effect within 6-12 hours. If given in the evening the medicine will take effect the next morning. Remember to use laxatives as little as possible and for no more than seven days. Contact your doctor if you feel no better. or if you feel worse or if the disorder occurs repeatedly or you have noticed a recent change in your characteristics.
Adults
The recommended dose is 2-4 coated tablets per day.
Children over 12 years of age
The recommended dose is 2-4 coated tablets per day.
Children aged between 10 and 12 years
The recommended dose is 1-2 coated tablets per day
Overdose What to do if you have taken too much Pursennid
If you take more Pursennid than you should
In case of accidental ingestion of an overdose of Pursennid, notify your doctor immediately or go to the nearest hospital.
If you have taken too much Pursennid you may have stomach pains, nausea and diarrhea.
If you have accidentally taken too many Pursennid tablets and have diarrhea, drink large amounts of fluids, especially fruit juices, and consult your doctor or pharmacist.
If you forget to take Pursennid
Take the normal recommended dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Pursennid
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Pursennid
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop the treatment and consult your doctor immediately if you or your child
- experience typical symptoms of an allergic reaction: o difficulty in breathing or swallowing o swelling of the face, lips, tongue or throat o severe itching of the skin with redness or swelling
- experience persistent abdominal pain, nausea and diarrhea with excessive fluid loss
- if constipation continues or worsens during Pursennid treatment
Side effects that may occur after taking Pursennid:
- cramps
- stomach ache
- colon pain
- excessive fluid loss (dehydration)
- low blood pressure
- tiredness
- muscle cramps and weakness
- loss of salts from the body
- deficiency of calcium and magnesium
- kidney problems
- increased activity of the adrenal glands (hyperaldosteronism).
Side effects that may occur after prolonged use of Pursennid:
- nausea and diarrhea with loss of water and potassium (hypokalaemia)
- slowed colon movements (atonic colon)
- drug addiction
- urine staining.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on safety. of this medicine.
Expiry and Retention
Store in the original package.
This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiration date which is on the package after Expiry. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
It is important to have the information about the medicine available at all times, so keep both the box and the package leaflet.
Contents of the pack and other information
What Pursennid contains
- The active ingredient is sennosides A + B. Each coated tablet contains 12 mg of sennosides A + B.
- The other ingredients are lactose monohydrate, stearic acid, talc, maize starch, anhydrous glucose, sucrose, gum arabic, colloidal anhydrous silica, titanium dioxide, cetyl palmitate.
What Pursennid looks like and contents of the pack
Pursennid comes in the form of round, biconvex, off-white coated tablets, packed in a blister.
Each pack of Pursennid 12 mg coated tablets contains 30 or 40 coated tablets
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
PURSENNID 12 MG COATED TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One coated tablet contains:
- Active ingredient: sennosides A + B (as calcium salts) 12 mg.
- Excipients with known effects: Lactose monohydrate; anhydrous glucose; sucrose.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Round, biconvex, off-white coated tablet.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Short-term treatment of occasional constipation.
04.2 Posology and method of administration
Dosage
Adults and children over 12 years of age: 2-4 coated tablets per day.
Children between 10 and 12 years: 1-2 coated tablets per day.
After a short period of treatment without appreciable results, consult your doctor.
The correct dose is the minimum sufficient to produce an easy evacuation of soft stools. It is advisable to initially use the minimum doses provided. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated.
Pediatric population
Contraindicated in children under 10 years of age.
Method of administration
Take preferably in the evening. The action of Pursennid occurs after 6-12 hours. Administered in the evening, the effect of Pursennid appears the next morning.
Laxatives should be used as infrequently as possible and for no more than seven days. The use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case.
Swallow with an adequate amount of water (a large glass).
A diet rich in liquids promotes the effect of the medicine.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Contraindicated if the following medical conditions exist:
- Inflammatory diseases of the digestive system (ie Crohn's disease, ulcerative colitis, liver disease, peritonitis and inflammatory bowel diseases).
- Irritation or obstruction of the gastrointestinal tract (ie spastic constipation, obstruction of the ileus / preileus, cramps and pains, nausea, vomiting and colic).
- Abdominal symptoms that may be due to an undiagnosed underlying condition, such as acute intestinal conditions that may require surgery (i.e. acute diverticulitis, appendicitis and massive diarrhea).
- states of severe dehydration, with loss of water and electrolytes, especially hypokalemia.
Contraindicated in children under 10 years of age.
04.4 Special warnings and appropriate precautions for use
The established dose should not be exceeded.
Prolonged indiscriminate use of laxatives can lead to addiction and deterioration of intestinal functions.
The lowest effective dosage should be used to restore normal bowel function. If no intestinal improvement has been achieved, the dosage can be increased under medical supervision.
Products containing senna and sennosides should only be used if a therapeutic effect cannot be obtained through a change in diet or the administration of bulking agents.
The use of these drugs requires medical supervision:
- if there are no positive effects following the treatment;
- if use is extended beyond one week of treatment;
- if the symptoms persist or worsen;
- after a laparotomy or abdominal surgery;
- if there are skin rashes, nausea and vomiting;
- in children between 10 and 12 years;
- during pregnancy and breastfeeding.
Information relating to excipients
- Lactose: Patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
- Glucose: Patients with rare glucose-galactose malabsorption problems should not take this medicine.
- Sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency, should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Concomitant use of other drugs that induce hypokalaemia (ie diuretics, adrenocorticosteroids and licorice) may increase electrolyte imbalance.
Hypokalaemia (resulting from the abuse of laxatives taken for a long time) potentiates the action of cardiac glycosides and interferes with antiarrhythmic drugs, with other drugs that induce the return to sinus rhythm (quinidine) and with drugs that induce elongation of the "QT interval.
04.6 Pregnancy and lactation
Pregnancy
There are no reports of side effects or harm during pregnancy and the fetus at the recommended dosage regimen. However, following experimental data concerning the genotoxic risk of various anthraquinones, emodin and aloe-emodin, use during pregnancy is not recommended.
Feeding time
Use during lactation is not recommended as there are insufficient data on the excretion of metabolites in breast milk. Small amounts of metabolites (reine) are excreted in breast milk. No laxative effect has been reported on breastfed infants. .
Fertility
Preclinical studies with sennosides do not indicate particular risks for fertility at therapeutically relevant doses.
04.7 Effects on ability to drive and use machines
This medicine does not affect the ability to drive or use machines.
04.8 Undesirable effects
This medicine can cause mild abdominal discomfort such as abdominal pain, cramps, irritation of the colonic and gastric mucosa.
Other effects such as dehydration, hypotension, fatigue, myopathy, stomach pain, hyponatremia, renal disorders, secondary aldosteronism, hypocalcemia and hypomagnesaemia have also been reported. These adverse reactions are usually reversible once the laxative is stopped.
Prolonged use or overdose of this drug can cause nausea, diarrhea with excessive loss of electrolytes, especially potassium (hypokalemia). There is also the possibility of developing megacolon. A brownish-yellow (pH-dependent) discoloration of the urine due to metabolites may occur during treatment and is of no clinical significance. Habituation has been reported after prolonged treatment.
Adverse reactions are listed below by system organ classes and frequency. Frequencies are defined as: very common (≥ 1/10),common (≥ 1/100, uncommon (≥ 1 / 1,000, rare (≥ 1 / 10,000; very rare (not known (cannot be estimated from the available data)).
Table 4-1 Undesirable effects in post-marketing experience
The adverse events listed above are based on post-marketing spontaneous reports and represent a less accurate estimate of the incidence that would be obtained in clinical trials.
Pediatric population
The same frequency, type and severity of adverse events are expected in children and adults.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. on the website of the Italian Medicines Agency: http://www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Symptoms
The most important symptoms related to overdose / overuse are abdominal colic and severe diarrhea resulting in loss of fluids and electrolytes, which must be replaced. Diarrhea especially can cause potassium loss, which can lead to cardiac disorders and muscle weakness, particularly when cardiac glycosides, diuretics, adrenocorticosteroids, or licorice root are administered at the same time.
Management
Treatment should be supportive with generous amounts of fluids. Electrolytes, especially potassium, need to be monitored. This is particularly important in the elderly. Chronic overdose of anthraquinone drugs can cause toxic hepatitis.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: stimulating laxative. ATC code: A06AB06.
Mechanism of action and pharmacodynamic effects
Senna glycosides are laxatives that selectively stimulate peristalsis of the large intestine. The active substance, senna, belongs to the group of anthraquinone stimulating laxatives. The stimulation of peristalsis is due to a direct action of the senna on the myenteric plexus that produces movements effective propulsive. Anthraquinone derivatives can also induce an "active secretion of electrolytes and water" inside the intestinal lumen and inhibit their absorption in the large intestine. This involves an increase in the volume of the intestinal bolus, with an increase in the filling pressure and therefore stimulation of peristalsis. Sennoside laxatives generally produce bowel movement within 6-12 hours.
05.2 Pharmacokinetic properties
Absorption
Sennoside laxatives are essentially prodrugs. The active ingredients, sennosides, are beta glycosides that are not absorbable from the upper part of the intestine nor can they be digested by human digestive enzymes. They are converted by bacteria in the large intestine into the active metabolite which is reinantrone. Animal experiments with radiolabelled reinantron administered directly into the cecum have shown an absorption of less than 10%.
Distribution and biotransformation
In contact with oxygen, reinantrone oxidizes into rhein and sennidine which can be found in the blood, especially in the form of glucuronides and sulphates.
Elimination
After oral administration of sennosides, ≈3% of the metabolites are excreted in the urine and some in the bile. Most sennosides (approx. 90%) are excreted in the faeces as polymers (polyquinones) together with 2-6% of sennosides. unchanged, sennidine, reinantrone and reina.
Metabolites, such as reine, pass to a small extent in breast milk.
05.3 Preclinical safety data
Single dose toxicity: senna, as a crude drug, has been shown to have very low toxicity in rats (LD50 of 5,000 mg / kg and 4,000 mg / kg respectively for male and female rats, respectively) and in mice (LD50> 5,000 mg / kg) after oral treatment.
Repeated dose toxicity In a multitude of tests, sennosides did not demonstrate specific toxicity when tested at doses of 30 mg / kg twice a week or at doses up to 500 mg / kg / week for 6 months. The toxic effects are caused by severe diarrhea which is the known pharmacological effect of senna.
Reproductive toxicity : There was no evidence of embryolethal, teratogenic or foetotoxic activity in rats and rabbits after oral treatment with sennosides. In addition, there was no effect of sennosides on the postnatal development of the young rats, or on the recovery behavior of the mothers or on the fertility of males and females in the rat.
Genotoxicity : the results of genotoxicity studies in vitro and in vivo as well as pharmacokinetic data in animals and humans have shown no risk of genotoxicity of senna, either in the presence or in the absence of metabolic activation.
Aloe-emodin and emodin, the metabolites that have shown signs of genotoxicity in some tests in vitro, have been confirmed as non-mutagenic in vivo in numerous tests, even when administered at very high doses of 1,000-2,000 mg / kg.
Carcinogenicity : Senna extract, the active ingredient of senna-based formulations, administered orally to rats for 2 years up to 25 mg / kg / day showed no tumorigenicity in the intestinal tract. No carcinogenicity was observed when Senna laxative was administered gavage to Sprague-Dawley rats once daily at dose levels of 0, 25, 100 and 300 mg / kg / day for up to 104 consecutive weeks.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lactose monohydrate; stearic acid; talc; cornstarch; anhydrous glucose; sucrose; Arabic gum; anhydrous colloidal silica; titanium dioxide, cetyl palmitate.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Opaque PVC blister - 30 or 40 coated tablets for oral use
06.6 Instructions for use and handling
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Novartis Consumer Health S.p.A., Largo U. Boccioni 1, Origgio (VA)
08.0 MARKETING AUTHORIZATION NUMBER
40 coated tablets: A.I.C. n. 004758025
30 coated tablets: A.I.C. n. 004758049
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
A.I.C renewal: 01.06.2010
10.0 DATE OF REVISION OF THE TEXT
25 February 2014
