PACKAGE LEAFLET: INFORMATION FOR THE USER

DICETEL

50 mg film-coated tablets
pinaverium bromide
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START 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, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Contents of this leaflet:

What DICETEL is and what it is used for
What you need to know before taking DICETEL
How to take DICETEL
Possible side effects
How to store DICETEL
Contents of the pack and other information

1. What DICETEL is and what it is used for

DICETEL is an oral antispasmodic containing pinaverium bromide. Pinaverium bromide
exerts an antispasmodic effect on intestinal muscle fibers and on the bile duct.
The intestine is a long, tubular muscular organ responsible for the passage and
digestion of food. The "bile duct" allows bile to pass from the liver to the intestine. If
the intestine or the bile duct undergo spasms and contract excessively, pain may occur.
This medicinal product acts by relieving spasms and pain.
DICETEL is indicated in esophageal motility disorders and biliary dyskinesias (alterations in the filling and emptying mechanisms of the gallbladder), functional colopathies, and irritable bowel syndrome.

2. What you need to know before taking DICETEL

Do not take DICETEL

If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking DICETEL.

The use of DICETEL is not recommended in children.
DICETEL may cause irritation of the esophagus; therefore, it is important that you take this medicine correctly:
always take the tablets during meals
the tablets must be swallowed whole with a glass of water. The tablets must not be crushed, sucked, or chewed.
do not take the tablets while lying down or just before lying down.
It is essential that you take DICETEL with particular care and in the correct manner, as described above, especially if:
you have any problems affecting the esophagus
you suffer from gastric or duodenal ulcer
you suffer from hiatal hernia (a condition in which a small portion of the stomach protrudes upward into the chest cavity).

Other medicines and DICETEL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking other medicines to relieve intestinal or bile duct spasms (so-called "anticholinergic drugs"). The administration of DICETEL together with anticholinergic drugs may increase spasmolysis.
Clinical studies have shown no interactions between pinaverium bromide and digitalis, oral antidiabetics, insulin, oral anticoagulants, or heparin at the therapeutic dose of 150 mg/day.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
There are no clinical data available on the use of DICETEL during pregnancy.
Animal studies are insufficient to demonstrate effects on pregnancy, embryonic/fetal development, birth, and/or postnatal development. The potential risk for humans is unknown.
DICETEL must not be used during pregnancy unless absolutely necessary.
The use of DICETEL towards the end of pregnancy may additionally cause neurological problems in the newborn (reduced muscle tone, sedation).

Breastfeeding
There are insufficient data on the secretion of DICETEL into human or animal breast milk. Available physicochemical and pharmacodynamic-toxicological data on DICETEL suggest that it may be secreted into breast milk; therefore, a risk to the breastfed newborn cannot be excluded.
DICETEL must not be used during breastfeeding.

Driving and using machines
No studies have been conducted on the effects on the ability to drive vehicles or operate machinery.
Observe how DICETEL affects you before performing any of these activities.

Important information about some excipients in DICETEL
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take DICETEL

Use this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

DICETEL may cause irritation of the oesophagus; therefore, it is important that you take this medicine correctly:
always take the tablets during meals
the tablets must be swallowed whole with a glass of water. The tablets must not be crushed, sucked, or chewed.
do not take the tablets while lying down or immediately before going to bed.
It is also recommended to:
take the tablets evenly spaced throughout the day.
try to take the tablets at approximately the same time each day. This may help you remember to take them.
The recommended dose is two or three tablets per day, according to the judgment of the doctor.

Use in children
The use of DICETEL is not recommended in children.
Your doctor will advise you how long to continue treatment.
If you take more DICETEL than you should:
In case of accidental ingestion/overdose of DICETEL, contact your doctor immediately or go to the nearest hospital. Bring the medicine pack and this patient information leaflet with you.
If you forget to take DICETEL:
Do not take a double dose to make up for the missed tablet. Take the next dose at the usual time.
If you stop taking DICETEL:
Caution: Do not stop taking DICETEL without consulting your doctor.
If you have any questions about the use of 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 during treatment with this medicine:

Immune system disorders
Allergic reactions (hypersensitivity) such as difficulty breathing or swelling of the face, lips,
tongue or throat. If any of these symptoms occur, stop taking DICETEL
and consult a doctor immediately – you may require urgent medical treatment.

Gastrointestinal disorders
Gastrointestinal disturbances such as stomach discomfort, abdominal pain, diarrhoea, nausea, vomiting,
feeling unwell and difficulty swallowing (dysphagia).
Oesophageal lesions may occur if the medicine is not taken as recommended.

Skin and subcutaneous tissue disorders
Skin-related side effects such as rash, itching, urticaria and redness.

Nervous system disorders
Headache, drowsiness and dizziness (frequency not known).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse.
Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting of side effects helps provide more information on the safety of this medicine.

5. How to store DICETEL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What DICETEL contains
The active substance is: pinaverium bromide 50 mg.
The excipients of the tablet core are: monohydrate lactose, anhydrous colloidal silica,
magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc.
The excipients of the tablet coating are: basic butyl methacrylate copolymer,
sodium lauryl sulfate, stearic acid, talc, hydroxypropyl methylcellulose, yellow iron oxide
E172 and red iron oxide E172.
Description of the appearance of DICETEL and package contents
DICETEL is available as orange-yellow film-coated, round, biconvex tablets, imprinted with "50" on one side and with a diameter of 8 mm.
They are packaged in PVC/aluminum blisters contained in boxes of 30 or 50 tablets.
Marketing Authorization Holder
Mylan Italia S.r.l.
Via Vittor Pisani 20
20124 Milano
Manufacturer
Mylan Laboratories SAS, Lieu Dit Maillard, Chatillon sur Chalaronne - France