Package leaflet: Information for the user

OBIMAL 40 mg coated tablets

otilonium bromide
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 could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What OBIMAL is and what it is used for

OBIMAL contains the active substance otilonium bromide, a compound with spasmolytic action (i.e.,
induces relaxation) on the smooth muscle of the gastrointestinal tract.
OBIMAL is used in adults for the treatment of:

irritable bowel syndrome (an intestinal disorder characterized by abdominal pain)
painful spastic manifestations (strong contractions of the muscles associated with pain) in the distal enteric tract (intestine).

2. What you need to know before taking OBIMAL

Do not take OBIMAL
If you are allergic to the active substance (octrilonium bromide) or to any of the other ingredients of
this medicinal product (listed in section 6);

Warnings and precautions
Talk to your doctor or pharmacist before taking OBIMAL.
Use OBIMAL with caution:

if you have glaucoma (increased internal pressure of the eye);
in case of prostatic hypertrophy (enlargement of the prostate);
in case of pyloric stenosis (a gastrointestinal disorder characterized by narrowing of the pylorus, the valve between the stomach and the intestine);

Children and adolescents
No data available

Other medicines and OBIMAL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interaction studies have been conducted.

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 taking this medicinal product.
If you are pregnant or breastfeeding, take OBIMAL only if clearly needed and under direct medical supervision.

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

OBIMAL 40 mg film-coated tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicinal product.

3. How to take OBIMAL

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 coated tablet taken orally, 2 to 3 times daily, according to the doctor's judgment.
The duration of treatment will be determined by the doctor.

If you take more OBIMAL than you should
In case of accidental ingestion or overdose of OBIMAL, contact your doctor immediately or go to the nearest hospital.
In animals, otilonium bromide has proven practically devoid of toxicity. Therefore, in humans, no significant problems due to overdose are expected.
In such cases, symptomatic and supportive treatment is advised.

If you forget to take OBIMAL
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use 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.
Cases of urticaria have been reported following the use of OBIMAL.

Reporting of side effects
If you experience any side effects, including those 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 following 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 OBIMAL

Keep this medicine out of the sight and reach of children.
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.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
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 OBIMAL contains
Each coated tablet contains:
Active ingredient: otilonium bromide 40 mg
Other components:
Core: lactose, starch, sodium starch glycolate, magnesium stearate.
Coating: hypromellose, titanium dioxide, macrogol, talc.

Description of the appearance of OBIMAL and contents of the pack
Round, biconvex, white or almost white coated tablets.
Blister pack containing 30 coated tablets in a cardboard box.

Marketing Authorization Holder
Malesci Istituto Farmacobiologico S.p.A. - Via Lungo l’Ema, 7 - Bagno a Ripoli (Florence)

Manufacturer
A.Menarini Manufacturing Logistics and Services s.r.l. – Via Campo di Pile – L’Aquila
A.Menarini Manufacturing Logistics and Services s.r.l. - Via Sette Santi, 3 – Florence
Berlin Chemie AG, Glienicker Weg 125 – Berlin (Germany)