Duspatal

PACKAGE LEAFLET: INFORMATION FOR THE USER

DUSPATAL 200 mg prolonged-release hard capsules

Mebeverine hydrochloride
PLEASE READ THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse.

Contents of this leaflet:

1. What DUSPATAL is and what it is used for
2. Before you take DUSPATAL
3. How to take DUSPATAL
4. Possible side effects
5. How to store DUSPATAL
6. Contents of the pack and other information

1. What DUSPATAL is and what it is used for

What DUSPATAL is
DUSPATAL belongs to a group of medicines called "antispasmodics", which act on the intestine.
The intestine is a long, tubular muscular organ responsible for the passage and digestion of food.
When the intestine spasms or contracts too much, pain is felt. This medicine works by relieving spasms and pain.

What DUSPATAL is used for
DUSPATAL is used to relieve symptoms caused by irritable bowel syndrome. These symptoms may vary from person to person but may include:

• abdominal cramps and pain
• bloating and flatulence
• diarrhoea, constipation, or a combination of both
• lumpy or small, hard pellet-like stools

2. Before taking DUSPATAL

Do not take DUSPATAL:

• If you are allergic to the active substance or to any of the other ingredients of this medicine
  (listed in section 6).
• If you have severe hepatic insufficiency (if your liver does not function properly).
• If you have paralytic ileus (lack of intestinal motility) or obstructive gastrointestinal disorders.
• If you have ulcerative colitis (chronic inflammation of the intestine) or toxic megacolon
  (intestinal dilation).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking DUSPATAL.
Use with caution in patients with mild to moderate renal insufficiency (if your kidneys do not function properly), mild to moderate hepatic insufficiency (if your liver does not function properly), or cystic fibrosis (a genetic disease mainly affecting the lungs and pancreas).

Children
Since there are no data available on the use of DUSPATAL capsules in children under 10 years of age, the use of this product is not recommended in this age group.

Other medicines and DUSPATAL
Inform 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 conducted in animals have shown no interaction between DUSPATAL and ethanol.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
DUSPATAL is not recommended during pregnancy. Your doctor may advise you to discontinue DUSPATAL or to take an alternative medicine instead.

Breastfeeding
DUSPATAL should not be used by breastfeeding mothers. Your doctor may advise you to discontinue breastfeeding or recommend an alternative medicine if you wish to breastfeed.

Fertility
There are no clinical data available on male or female fertility.

Driving and using machines
DUSPATAL does not impair the ability to drive or operate machinery.

3. How to take DUSPATAL

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. Do not crush or chew them.
• Try to take the capsules at the same time each day.

How much medicine to take
Adults and children over 10 years of age

• The usual dose is one 200 mg capsule twice daily.
• Take one capsule in the morning and one capsule in the evening.

Do not administer Duspatal 200 mg capsules to children under 10 years of age.
If you take more Duspatal than you should

If you take more Duspatal than you should, inform your doctor or go to hospital immediately.
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 your usual time.
• Do not take a double dose to make up for a forgotten dose.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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 contact your doctor immediately if you notice any of the following serious side effects – you may need urgent medical treatment:

• Breathing difficulties, swelling of the face, neck, lips, tongue or throat. You may be experiencing a severe allergic reaction (hypersensitivity) to the medicine.

Other side effects include:

• You may experience a milder allergic reaction to the medicine: e.g. skin rash, red and itchy skin.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website "www.agenziafarmaco.gov.it/it/responsabili".
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DUSPATAL

• Do not store above 30°C; do not refrigerate; do not freeze; keep in the original packaging.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Duspatal contains
The active substance is mebeverine hydrochloride.
The other components are:

• components of the granules contained within the capsules: magnesium stearate, ethyl acrylate and methyl methacrylate copolymer, talc, hypromellose, methacrylic acid and ethyl acrylate copolymer (1:1), triacetin.
• components of the capsule coating: gelatin, titanium dioxide.
• components of the printing ink on the capsules: shellac (E904), propylene glycol, concentrated ammonia solution, potassium hydroxide, black iron oxide (E172).

Description of the appearance of Duspatal and contents of the pack
Duspatal prolonged-release hard capsules.
The capsules are hard gelatin capsules of size no. 1, opaque white in colour, imprinted with "245".
The capsules are supplied in PVC/aluminum blisters containing 20 capsules.

Marketing Authorization Holder
MYLAN ITALIA S.R.L.
VIA VITTOR PISANI, 20
20124 - MILANO

Manufacturer
Manufacturer of the granules:
Abbott Biologicals B.V., Olst - Netherlands.
Final manufacturer and controller:
Mylan Laboratories SAS, Route de Belleville – Lieu dit Maillard, Châtillon sur Chalaronne,
France.