DIGERENT POLIFARMA

Package leaflet: Information for the patient

Digerent Polifarma

150 mg hard capsules
Trimebutine maleate
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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Digerent Polifarma is and what it is used for
2. What you need to know before taking Digerent Polifarma
3. How to take Digerent Polifarma
4. Possible side effects
5. How to store Digerent Polifarma
6. Contents of the pack and other information

1. What Digerent Polifarma is and what it is used for

Digerent Polifarma contains trimebutine maleate, which belongs to a class of medicines called synthetic antispasmodics, used to treat functional gastrointestinal disorders.
Digerent Polifarma is used in adults to treat the following conditions:

• irritable bowel syndrome (inflammatory bowel condition)
• cramps and stomach and intestinal pain

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Digerent Polifarma

Do not take Digerent Polifarma

• if you are allergic to trimebutine maleate or to any of the other ingredients of this medicine (listed in section 6 “What Digerent Polifarma contains”)
• during the first 3 months of pregnancy or if you are breastfeeding.
• if you have intestinal obstruction caused by bowel paralysis (paralytic ileus) or other conditions characterized by gastrointestinal tract obstruction
• if you have ulcerative colitis, a chronic inflammatory and ulcerative disease of the colon
• if you have toxic megacolon, a condition characterized by marked dilation of the colon
• in children under 2 years of age

Warnings and precautions
Talk to your doctor or pharmacist before taking Digerent Polifarma.
Children and adolescents
Digerent Polifarma is not indicated for use in children and adolescents, as safety and efficacy have not
been established in this patient group.
Other medicines and Digerent Polifarma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
No interactions between trimebutine maleate and other drugs are known.
Digerent Polifarma with food and drinks
Digerent Polifarma can be taken either on an empty or full stomach.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during the first three months of pregnancy or while breastfeeding.
Clinical studies with Digerent Polifarma on fertility have not been conducted.
Driving and using machines
Digerent Polifarma may cause dizziness and drowsiness that could affect your ability to drive
vehicles and operate machinery. If you experience or have previously experienced these symptoms, avoid driving or using
machinery.

3. How to take Digerent Polifarma

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose in adults is: one hard capsule 2-3 times daily, for oral use.
If necessary, your doctor may increase the dose up to 4 capsules per day.
Unless otherwise prescribed by your doctor, Digerent Polifarma should not be taken for longer than 8 weeks.
You may take Digerent Polifarma before or after meals (See Section 2 “Digerent Polifarma with food and
drinks”).

Use in children and adolescents
Not recommended for use in children and adolescents, as safety and efficacy have not been established
in this patient group.

If you take more Digerent Polifarma than you should
In case of accidental overdose of Digerent Polifarma, contact your doctor immediately or go to the nearest hospital.
Cases of intentional abuse, suicide attempts or accidental overdose with trimebutine have been reported. Excessive doses of trimebutine have caused loss of consciousness, coma, drowsiness, seizures, speech disorders, pupillary constriction, transient interruptions of breathing, profuse sweating, rapid heartbeat, high blood pressure, and changes in the electrocardiogram.
These effects have occurred within 3 hours after ingestion of an excessive dose of trimebutine.

If you forget to take Digerent Polifarma
Do not take a double dose to make up for the missed capsule.

If you stop taking Digerent Polifarma
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon side effects (may affect up to 1 in 100 people)

• Headache
• Abdominal pain
• Constipation
• Diarrhoea
• Dry mouth
• Indigestion
• Nausea
• Vomiting
• Skin rash
• Itching
• Fatigue

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Mental disorders related to substance use and dependence
• Drowsiness
• Dizziness
• Temporary loss of consciousness
• Fainting
• Urticaria
• Erythema
• Allergic reactions
  Anaphylaxis (severe allergic reaction)
  Severe skin reactions (erythema multiforme, widespread red and scaly rash, with formation of subcutaneous pustules and localized blisters, accompanied by fever at the beginning of treatment)

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly through 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 the safety of this medicine.

5. How to store Digerent Polifarma

Keep this medicine out of the sight and reach of children.
Store below 30 °C.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”
The expiry date refers to the last day of that month.
Do not use this medicine if you notice any changes in the colour of the capsule.
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 Digerent Polifarma contains

• The active substance is: trimebutine maleate 150 mg
• The other components are: maize starch; talc; magnesium stearate; titanium dioxide (E 171); gelatin.

Description of the appearance of Digerent Polifarma and package contents
White, hard capsules.
Carton pack containing 30 hard capsules packed in three PVC blisters of 10 capsules each.
Carton pack containing 20 hard capsules packed in two PVC blisters of 10 capsules each.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
POLIFARMA S.p.A.
Viale dell’Arte, 69
00144 Rome

Manufacturers
ICE S.p.A.
Cantone Moretti, 29
10015 Ivrea (TO)
Or
ISTITUTO DE ANGELI S.r.l.
Località Prulli n. 103/C
50066 Reggello (FI)
Or
MIPHARM S.p.A.
Via B. Quaranta, 12
20141 Milan (MI)