Active ingredients: Mebeverina (Mebeverine hydrochloride)
DUSPATAL 200 mg prolonged-release hard capsules
Why is Duspatal used? What is it for?
Meaning of Duspatal
DUSPATAL belongs to a group of drugs called "antispasmodics" which act on the intestine. The intestine is a long, tubular-shaped muscular organ that serves for the passage and digestion of food. If the bowels spasm or contract too much, pain is felt. This medicine works by relieving the spasm and pain.
What Duspatal is used for
Duspatal is used to relieve symptoms of irritable bowel syndrome. These symptoms vary from person to person but can include:
- stomach cramps and pain
- feeling of bloating and flatulence
- diarrhea, constipation or a combination of both
- I made small hard balls or cords
Contraindications When Duspatal should not be used
If you are allergic to the active substance or any of the other ingredients of this medicine
If you have severe liver failure (if your liver is not functioning well).
If you suffer from paralytic ileus (lack of bowel motility) and obstructive pathology of the gastrointestinal system.
If you have ulcerative colitis (chronic inflammation of the gut) and toxic megacolon (dilation of the gut).
Precautions for use What you need to know before taking Duspatal
Talk to your doctor, pharmacist or nurse before taking Duspatal.
Use with caution in people with mild to moderate kidney failure (if your kidneys are not working well), mild to moderate liver failure (if your liver is not working well), cystic fibrosis (genetic disease that predominantly affects the lungs and pancreas) .
Children
As there are no data on the use of DUSPATAL capsules in children under 10 years, the use of the product is not recommended in this age group.
Interactions Which drugs or foods can change the effect of Duspatal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. No interaction studies have been performed except with alcohol. "In vitro" and "in vivo" studies in animals have shown the absence of interaction between Duspatal and ethanol.
Warnings It is important to know that:
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
Duspatal is not recommended during pregnancy. Your doctor may tell you to stop taking Duspatal or take another medicine instead of Duspatal.
Feeding time
Duspatal should not be used by mothers who are breastfeeding. Your doctor may tell you to stop breastfeeding or advise you to take another medicine if you want to breastfeed.
Fertility
There are no clinical data on male or female fertility.
Driving and using machines
No studies on the ability to drive and use machines have been performed.
Dose, Method and Time of Administration How to use Duspatal: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Taking this medicine
- Swallow the capsules whole with a full glass of water. Don't crush or chew them.
- Try to take the capsules at the same time every day.
How much medicine to take
Adults and children over 10 years of age
- The usual dose is one 200 mg capsule twice a day.
- Take one capsule in the morning and one capsule in the evening.
Do not give Duspatal 200 mg capsules to children under 10 years of age.
Overdose What to do if you have taken too much Duspatal
If you take more Duspatal than you should
If you take more Duspatal than you should, tell your doctor or go to a hospital straight away. Take the medicine pack and this leaflet with you.
If you forget to take Duspatal
- If you forget to take a dose, skip the missed dose. Take the next dose at the usual time.
- Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
Side Effects What are the side effects of Duspatal
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Stop taking Duspatal and see your doctor immediately, if you notice any of the following serious side effects - you may need urgent medical treatment:
- Difficulty breathing, swelling of the face, neck, lips, tongue or throat. You may have a severe allergic (hypersensitivity) reaction to the medicine.
Other side effects include:
- You may experience a minor allergic reaction to the medicine: eg. skin rash, red itchy skin.
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Expiry and Retention
Do not store above 30 ° C, do not refrigerate, do not freeze, store in the original packaging.
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 carton and blister after EXP. 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.
What Duspatal contains
The active ingredient is mebeverine hydrochloride.
The other ingredients are:
- the components that make up the granules contained inside the capsules: magnesium stearate, copolymer of ethyl acrylate and methyl methacrylate, talc, hypromellose, copolymer of methacrylic acid and ethyl acrylate (1: 1), triacetin.
- the components of the capsule shell are: gelatin, titanium dioxide.
- the components of the printing ink of the capsules: shellac (E904), propylene glycol, concentrated ammonia solution, potassium hydroxide, black iron oxide (E172).
What Duspatal looks like and contents of the pack
Duspatal prolonged-release hard capsules.
The capsules are hard gelatin capsules of size No. 1, opaque white, imprinted with 245.
The capsules are supplied in PVC / Aluminum blisters containing 20 capsules.
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
DUSPATAL 200 MG HARD RELEASE CAPSULES
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release capsule, hard contains 200 mg of mebeverine hydrochloride.
For the full list of excipients see section 6.1
03.0 PHARMACEUTICAL FORM
Prolonged-release hard capsules.
Hard gelatin capsule size n. 1, opaque white, imprinted with 245.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Adults and children over 10 years of age
Irritable colon.
04.2 Posology and method of administration
For oral use
Adults and children over 10 years of age
One 200 mg capsule twice a day, one in the morning and one in the evening.
In the absence of data on long-term treatment, the physician should evaluate discontinuing treatment as soon as the desired effect is achieved.
Special patient groups
No dosing studies have been conducted in the elderly, in patients with renal and / or hepatic impairment.
DUSPATAL should be used with caution in patients with severe renal insufficiency and mild or moderate hepatic insufficiency.
Children under the age of 10
As there are no data on the use of DUSPATAL capsules in children under 10 years, the use of the product is not recommended in this age group.
Method of administration
The capsules should be swallowed with a sufficient amount of water (at least 100 ml) and should not be chewed, as the coating is intended to provide a sustained release mechanism of action (see section 5.2).
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe hepatic insufficiency. Paralytic ileus.
04.4 Special warnings and appropriate precautions for use
Use with caution in people with mild to moderate renal insufficiency, mild to moderate hepatic insufficiency, cystic fibrosis, obstructive pathology of the gastrointestinal tract, ulcerative colitis and toxic megacolon.
As there are no data on the use of DUSPATAL capsules in children under 10 years, the use of the product is not recommended in this age group.
04.5 Interactions with other medicinal products and other forms of interaction
No interaction studies have been performed except with alcohol. Education "in vitro" And "in vivo" conducted on animals showed the absence of interaction between Duspatal and ethanol.
04.6 Pregnancy and lactation
Pregnancy
There are no or limited data from the use of mebeverine in pregnant women. Animal studies are insufficient to demonstrate reproductive toxicity (see section 5.3). Duspatal is not recommended during pregnancy.
Feeding time
It is not known whether mebeverine or its metabolites are secreted in human milk. The secretion of mebeverine in animal milk has not been studied.
DUSPATAL should not be used during breastfeeding.
Fertility
There are no clinical data on male or female fertility; however, animal studies do not indicate harmful effects of Duspatal (see section 5.3)
04.7 Effects on ability to drive and use machines
No studies on the ability to drive and use machines have been performed.
04.8 Undesirable effects
The following undesirable effects have been reported after marketing.
Based on the available data it was not possible to make a precise assessment of the frequency (frequency not known).
Allergic reactions mainly but not exclusively to skin localization have been observed.
Disorders of the immune system:
Hypersensitivity (anaphylactic reactions).
Skin and subcutaneous tissue disorders
Urticaria, angioedema, face edema, rash.
04.9 Overdose
In the event of an overdose, hyperexcitability of the central nervous system could theoretically occur.
In cases of mebeverine overdose, symptoms were absent or mild and generally rapidly reversible. The symptoms observed from overdose were neurological and cardiovascular in nature.
A specific antidote is not known and symptomatic treatment is recommended. Gastric lavage should be considered if multiple intoxications are discovered within approximately one hour.
Absorption reduction measures are not necessary.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: drugs for functional intestinal disorders, synthetic anticholinergics, esters with tertiary amino groups.
ATC code: A03AA04
Mechanism of action and pharmacodynamic effects
Mebeverine is a musculotropic antispasmodic with a direct action on intestinal smooth muscle, where it resolves the spasm without affecting normal intestinal motility.
In studies in vitro it has been shown that mebeverine acts directly on smooth muscle fiber cells by reducing sodium permeability and indirectly the entry of calcium and therefore muscle contraction. Mebeverine can also indirectly reduce the release of potassium from the cell by preventing muscle hypotonia.
Mebeverine has no anticholinergic effects.
Pediatric population
Clinical trials with tablet or capsule formulations have only been conducted in adults.
05.2 Pharmacokinetic properties
Absorption
Orally administered capsules release gastro-resistant microspheres into the stomach.
The microspheres based on mebeverine hydrochloride reach the intestine where there is a prolonged release of the active principle.
Mebeverine is completely absorbed in the intestinal tract after oral administration of the capsules.
The extended release formulation allows for a dosage schedule of 2 capsules per day.
Distribution
No accumulation was observed after repeated administration.
Biotransformation
Mebeverine hydrochloride is mainly metabolized during passage through the intestinal wall and in the liver by esterases which primarily break the ester bonds into veratric acid and mebeverin alcohol.
The major metabolite in plasma is DMCA (demethylated carboxylic acid).
The steady-state elimination half-life of the DMCA is 5.77 hours. After multiple dosing (200 mg twice daily) the Cmax of the DMCA is 1400 ng / mL.
The relative bioavailability of the prolonged-release capsules appears to be optimal with a mean ratio greater than 90%.
Elimination
Mebeverine is not excreted as such, but is completely metabolized; the metabolites are almost completely excreted. Veratric acid is excreted in the urine, mebeverin alcohol is also excreted in the urine, partially as carboxylic acid (MAC) and partially as demethylated carboxylic acid (DMCA).
Pediatric population
No pharmacokinetic studies have been conducted in children with any formulation of mebeverine.
05.3 Preclinical safety data
During development, mebeverine has been studied in numerous animal species in acute, subacute and chronic toxicity tests and in reproduction studies.
In single and repeated oral dose toxicity tests, central nervous system effects with behavioral excitement (mainly tremor and convulsions) were observed in rats, rabbits and dogs. Seizures were reported in dogs at doses equivalent to 2 times the maximum human dose of 400 mg per day. The reproductive toxicity of mebeverine has not been sufficiently investigated in animal studies. There is no indication of teratogenic power in rats. and in rabbits for doses up to 100 mg / kg per day in a single administration. However, embryotoxic effects (reduction in growth, embryonic mortality) were noted in rats at 50 mg / kg twice a day. This effect was not seen. in rabbits.
In an oral fertility study in female and male rats, no effect was observed in F0 and three F1 generations up to a dose of 50 ng / kg per day.
In both species no teratogenic effects were found.
In test "in vitro" And "in vivo" on genotoxicity, mebeverine was found to have no genotoxic effects. Carcinogenicity studies have not been conducted as there is no suspicion of carcinogenic potential.
In a study conducted to investigate the potential effect of mebeverine and mebeverinic acid at the level of human liver microsomes on the cytochrome CYP2E1 system which metabolizes ethanol, neither mebeverine nor mebeverinic acid inhibited CYP2E1.
The effects of mebeverine and ethanol on motor coordination in rats were investigated. The results of the study showed that doses up to 6 times the maximum therapeutic dose of mebeverine affect motor coordination in both the presence and absence of ethanol. Mebeverine it did not enhance the effect of ethanol.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Capsule contents (granules): Magnesium stearate, copolymer of ethyl acrylate and methyl methacrylate, talc, hypromellose, copolymer of methacrylic acid and ethyl acrylate (1: 1), triacetin.
Capsule shell: gelatin, titanium dioxide (E171).
Capsule printing ink: shellac (E904), propylene glycol, concentrated ammonia solution, potassium hydroxide, black iron oxide (E172).
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Store at a temperature not exceeding 30 ° C, do not refrigerate, do not freeze, store in the original package.
06.5 Nature of the immediate packaging and contents of the package
PVC and aluminum blister, 20 capsule box.
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
Abbott Healthcare Products B.V., Weesp - The Netherlands.
Licensee for sale in Italy:
Abbott S.r.l. - S.R. 148 Pontina km 52 snc - 04011 Campoverde di Aprilia (LT)
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 021377039.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
First authorization: 19/06/1981.
Renewal: 31/05/2010
10.0 DATE OF REVISION OF THE TEXT
AIFA Determination of May 14, 2013
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