Duspatalin Mebeverine (Generic Colofac)

DUSPATALIN (Generic Colofac)
It is administered orally.

Active ingredient
Each capsule contains mebeverine hydrochloride.

Excipients
Capsule (granules): Magnesium stearate, polyacrylate dispersion 30%, talc, hypromellose, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, glycerol triacetate

Capsule shell: Gelatin, titanium dioxide (E171), printing inks: shellac (E904), black iron oxide (E172), propylene glycol, strong ammonia solution, potassium hydroxide

1. What is DUSPATALIN (Generic Colofac) and what is it used for?

DUSPATALIN (Generic Colofac) is an opaque white hard gelatin capsule containing 200 mg mebeverine hydrochloride. It is used orally.

Mebeverine is directly active in the gastrointestinal tract without disturbing normal bowel movements.

It works by solving the contractions. Since this effect of DUSPATALIN (Generic Colofac) does not occur with the autonomic nervous system range, it does not show typical anticholinergic side effects.

DUSPATALIN (Generic Colofac) is used in adults and children over 10 years of age to treat the following conditions:

• Symptomatic treatment of abdominal pain and cramps, intestinal discomfort and intestinal discomfort associated with irritable bowel syndrome.

• Treatment of gastrointestinal spasms due to organic disorders.

2.How to use DUSPATALIN (Generic Colofac)?
Instructions for proper use and dose/frequency of administration

The recommended dosage of DUSPATALIN (Generic Colofac) for adults and children over 10 years old; It is 1 200 mg capsule to be taken 2 times a day, one in the morning and one in the evening.

Your doctor will tell you how long you should take DUSPATALIN (Generic Colofac). However, in general, the period of use is not limited.

Application route and method

DUSPATALIN (Generic Colofac) is for oral use only.

Capsules should be swallowed with a sufficient amount of water (at least 100 ml (one glass) of water), not chewed; because the purpose of the coating is to provide a prolonged release mechanism.

Follow these instructions unless your doctor makes a separate recommendation.

different age groups

Use in children

In the 3-10 age group, 200 mg retard capsules should not be used due to the high amount of active substance.

Use in the elderly

cannot be identified. No special adjustment of Duspatalin dose is required in this group of patients.

Special use cases:

Kidney/Liver failure:

A specific risk for patients with renal or hepatic impairment cannot be identified with available post-marketing data.

No dosage adjustment is required in patients with renal or hepatic impairment.

If you have the impression that the effect of DUSPATALIN (Generic Colofac) is too strong or too weak, talk to your doctor or pharmacist.

3. What are the possible side effects?

Like all medicines, DUSPATALIN (Generic Colofac) may have side effects in people who are sensitive to the ingredients in its content.

If any of the following occur, stop using DUSPATALIN (Generic Colofac) and IMMEDIATELY inform your doctor or go to the nearest hospital emergency department:

Allergic reactions:

- anaphylactic reactions (very serious and rapidly developing reactions)

- urticaria (hives)

- angioedema (swelling of the face and throat as a result of allergies)

- face edema

- exanthema (rash/redness)

These are all very serious side effects. If you have one of these, you have a serious allergy to DUSPATALIN (Generic Colofac). You may need emergency medical attention or hospitalization.

All of these very serious side effects are very rare.

2. Before you use DUSPATALIN (Generic Colofac)
DO NOT USE DUSPATALIN in the following conditions
If you are allergic to the active substance (mebeverine hydrochloride) in the content of DUSPATALIN (Generic Colofac) or any

Do not use DUSPATALIN (Generic Colofac) if you are allergic (hypersensitive) to a component of it.

Using DUSPATALIN (Generic Colofac) with food and drink

Using DUSPATALIN (Generic Colofac) with food and drink

Pregnancy

Consult your doctor or pharmacist before using this medication.

Very limited information is available regarding the use of Duspatalin (Generic Colofac) in pregnant women. Do not use DUSPATALIN (Generic Colofac) if you are pregnant.

Breast-feeding

Consult your doctor or pharmacist before using this medication.

It is not known whether mebeverine or its metabolites are excreted in human breast milk.

Do not use DUSPATALIN (Generic Colofac) if you are breastfeeding.

Fertility

There is no clinical information on the effect of DUSPATALIN (Generic Colofac) on male or female fertility; however, animal studies have not shown a harmful effect of Duspatalin.

Vehicle and machine use

No studies on the effects of DUSPATALIN (Generic Colofac) on the ability to drive and use machines have been performed.