Active ingredients: Bisacodyl
Lovoldyl 5 mg coated tablets
Why is Lovoldyl used? What is it for?
Lovoldyl contains the active substance bisacodyl.
Lovoldyl is a drug belonging to the class of contact laxatives which act by direct contact with the internal wall of the intestine, favoring the elimination of solid and liquid residues from the intestine.
Lovoldyl is used to prepare the intestine for examinations (endoscopies or x-rays) and colon surgery.
Contraindications When Lovoldyl should not be used
DO NOT use Lovoldyl
- if you are allergic to bisacodyl or any of the other ingredients of this medicine (listed in section 6)
- in case of acute abdominal pain or of unknown origin
- nausea or vomiting
- intestinal blockage caused by occlusive or restrictive forms (intestinal obstruction or stricture) blockage or slowing down of food in the intestinal tract (paralytic ileus)
- rectal bleeding of unknown origin
- in case of acute abdominal pain of surgical emergency (acute surgical abdomen) severe state of dehydration
- active inflammatory bowel disease
- stomach and intestinal disorders (gastroenteritis) or appendicitis
- in children under 3 years of age
- in pregnancy and lactation (see section "Pregnancy, lactation and fertility").
Precautions for use What you need to know before taking Lovoldyl
Talk to your doctor or pharmacist before using Lovoldyl.
Use Lovoldyl with caution:
- if you are an elderly patient
- if you have kidney problems (severe kidney failure)
In these cases, dehydration due to intestinal fluid loss can be dangerous.
Tell your doctor if:
- suffer from inflammatory bowel disease
- have abdominal pain
- you have nausea or vomiting. The use of laxatives in the conditions mentioned above can be dangerous so your doctor will make a careful evaluation.
Keep in mind that:
- There have been isolated reports of abdominal pain and diarrhea with blood loss after taking Lovoldyl. Some cases have been associated with reduced blood supply (ischemia) to the lining of the colon.
Children
Do not give Lovoldyl to children under 3 years of age. The use of Lovoldyl in children under 10 years of age is not recommended, as the efficacy and safety of Lovoldyl for bowel preparation in this age group has not been adequately demonstrated.
Interactions Which drugs or foods can modify the effect of Lovoldyl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- Leave an interval of at least 2 hours after taking other medicines before taking Lovoldyl, because laxatives reduce the time spent in the intestine by affecting their absorption.
- Use Lovoldyl at least one hour after taking medicines to fight stomach acid (antacids) as they can change their effect.
- If you use the laxative concomitantly with medicines that increase urine production (diuretics) and cortisone-based medicines (corticosteroids) you may increase the risk of body salt imbalance (electrolyte imbalance) which in turn leads to increased sensitivity to medicines for the heart (cardiac glycosides).
Lovoldyl with food and drink
Use Lovoldyl at least one hour after consuming milk and its derivatives as they can modify the effect of the laxative.
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.
No studies have been conducted to investigate the effects on human fertility.
There are no adequate studies on the use of bisacodyl in pregnancy. Clinical data show that the active form of bisacodyl and its derivatives do not pass into breast milk.
During pregnancy and breastfeeding, use Lovoldyl only after consulting your doctor and evaluating the risk / benefit ratio with him.
Driving and using machines
The medicine does not normally affect the ability to drive and use machines. Avoid driving vehicles if you feel dizzy.
Lovoldyl contains lactose and sucrose
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 Lovoldyl: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Use Lovoldyl according to the instructions received from the medical center where the examination or surgery is performed. Follow the instructions carefully to ensure the success of the examination (eg colonoscopy).
The recommended dose for adults is:
2-4 coated tablets (10-20 mg) as part of a medically indicated bowel preparation scheme.
Use in children over 10 years of age
The recommended dose is 2 coated tablets (10 mg) as part of a medically directed bowel preparation scheme.
The use of Lovoldyl in children under 10 years of age is not recommended.
Use Lovoldyl tablets:
whole, without chewing, with a large glass of water.
at least 1 hour after taking milk and antacid medicines.
at least 2 hours after taking other medicines by mouth.
Overdose What to do if you have taken an overdose of Lovoldyl
Tell your doctor immediately or go to the nearest hospital if you have taken too much Lovoldyl.
Too high doses of the medicine can cause abdominal pain and diarrhea with consequent loss of fluids and mineral salts that must be replenished.
Side Effects What are the side effects of Lovoldyl
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare cases of hypersensitivity reactions have been reported such as:
- severe and sudden allergic reaction (anaphylaxis)
- rapid swelling of the skin (angioedema)
- red and itchy skin (rash)
There have been isolated reports of:
- abdominal cramps or pains (colic)
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 www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not use this medicine if the pack has been opened or damaged.
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.
Keep the carton and the accompanying leaflet so that you always have the information about the medicine available.
Other information
What Lovoldyl contains
One coated tablet contains:
- The active ingredient is bisacolide 5 mg.
- The other ingredients of the medicine are: lactose, corn starch, sucrose, talc, glyceryl behenate, magnesium carbonate, methacrylic copolymers, PEG 4000, titanium dioxide.
What Lovoldyl looks like and contents of the pack
Lovoldyl is presented in packs of 4 coated tablets for oral use in blister packs.
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
LOVOLDYL 5 MG COATED TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One coated tablet contains:
Active principle: Bisacodyl 5 mg.
Excipients: Lactose 60 mg, Sucrose 20 mg. For the complete list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Coated tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Intestinal preparation for diagnostic procedures (endoscopic or radiological) and colon surgery.
04.2 Posology and method of administration
For bowel preparation for endoscopic or radiological procedures of the colon, the instructions received from the Center should be carefully followed to ensure the success of the examination. The coated tablets should be swallowed whole, without chewing.
Adults: 2-4 coated tablets (10-20 mg) as part of a medically indicated bowel preparation scheme. A common scheme is as follows: bisacodyl tablets are taken 4-6 hours before a 2-liter macrogol-based iso-osmotic intestinal lavage solution.
Children over 10 years of age: 2 coated tablets (10 mg) as part of a medically indicated bowel preparation scheme.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients. Laxatives are contraindicated in people with acute abdominal pain or of unknown origin, nausea or vomiting, paralytic ileus, intestinal obstruction or stenosis, acute surgical abdomen, appendicitis, gastroenteritis, rectal bleeding of unknown origin, active inflammatory bowel disease, abdominal pain acute, severe state of dehydration. Contraindicated in children under 3 years of age. Contraindicated in pregnancy and lactation (see section 4.6).
04.4 Special warnings and appropriate precautions for use
The use of laxatives in patients with inflammatory bowel disease or in the presence of abdominal pain, nausea or vomiting can be dangerous and therefore requires careful consideration by the physician. Intestinal fluid loss can cause dehydration. Symptoms may be thirst and oliguria. In patients, for whom dehydration can be dangerous (patients with severe renal insufficiency, elderly patients), treatment with LOVOLdyl requires caution. There have also been isolated reports of abdominal pain and haemorrhagic diarrhea after the intake of bisacodyl. Some cases have been related to colonic mucosal ischemia. The efficacy and safety of bisacodyl for intestinal preparation in children under the age of 10 has not been adequately demonstrated. Therefore, the use of the product for this indication is not recommended in children under 10 years of age. . Caution is required in patients with inflammatory bowel disease.
Important information about some of the excipients: LOVOLdyl tablets contain lactose and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose malabsorption, galactose, or sucrase isomaltase insufficiency should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Milk and its derivatives or antacids can modify the laxative effect therefore, it is advisable to take the medicine at least one hour apart. The concomitant use of diuretics or corticosteroids may increase the risk of electrolyte imbalance if you take a large quantity of bisacodyl. excessive. Electrolyte imbalance can lead to increased sensitivity to glycosides. Stimulant laxatives accelerate the transit of intestinal contents and can interfere with the absorption of drugs; therefore, it is advisable to allow an interval of at least two hours between taking the laxative and that of other oral medications.
04.6 Pregnancy and breastfeeding
No studies have been conducted to investigate the effects on human fertility. There are no adequate and well-controlled studies on the use of bisacodyl in pregnancy. Therefore, although no toxic effects have ever been reported during pregnancy, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus. Clinical data show that neither the active form of bisacodyl, bis- (p-hydroxyphenyl) -pyridyl-2-methane (BHPM), nor its glucuronic derivatives are excreted in breast milk, however the medicine should only be used when needed, under direct medical supervision, after evaluating the expected benefit to the mother in relation to the possible risk to the infant.
04.7 Effects on ability to drive and use machines
As a rule, the intake of the product does not affect the ability to drive and use machines.
04.8 Undesirable effects
Occasionally, isolated cramping pains, or abdominal colic may occur. Rare hypersensitivity reactions (rash, angioedema, anaphylaxis) have been reported.
04.9 Overdose
Signs and symptoms: Excessive doses can cause abdominal pain and diarrhea; consequent losses of fluids and electrolytes must be replaced.
Treatment: Within a short time after ingestion of LOVOLdyl, its effect can be minimized by inducing vomiting. Fluid replacement and correction of electrolyte imbalance (especially hypokalaemia) may be necessary. This is particularly important in elderly and young patients. Administration of spasmolytics may be helpful.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Therapeutic drug category: contact laxatives. ATC code: A06AB02. Pharmacological activities and mechanism of action: bisacodyl, active principle of the LOVOLdyl product, derived from diphenylmethane, belongs by virtue of its mechanism of action to contact laxatives. It increases peristalsis and intestinal transit speed and the water content in the stool. Bisacodyl tablets have an action time of approximately 6 hours, 8-12 hours if taken at bedtime. LOVOLdyl produces copious soft newly formed stools, which facilitate defecation in the case of hemorrhoids.
05.2 Pharmacokinetic properties
After oral administration bisacodyl is rapidly converted by intestinal and bacterial enzymes to the active desacetylated metabolite.
Absorption is approximately 5 percent of the administered dose and the product is excreted in the urine as a glucuronide. This metabolite is also excreted in the bile and can be hydrolyzed in the colon to form the active drug.
05.3 Preclinical safety data
There is no information, deriving from preclinical data, of significant importance to the physician that has not already been reported in the other sections of the Summary of Product Characteristics.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lactose, Corn starch, Sucrose, Talc, Glyceryl Beenate, Magnesium carbonate, Methacrylic copolymers, PEG 4000, Titanium dioxide.
06.2 Incompatibility
None known.
06.3 Period of validity
3 years in intact packaging.
06.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Lithographed cardboard box containing 4 tablets packed in blister packs made of heat-sealed PVC and aluminum.
06.6 Instructions for use and handling
No special instructions.
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
PROMEFARM S.r.l. Corso Indipendenza, 6 - 20129 MILAN.
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 034894030.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
20-07- 2001 / July 2011.
10.0 DATE OF REVISION OF THE TEXT
November 2011.
