SPASMOMEN

Package leaflet: Information for the user

SPASMOMEN 40 mg film-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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SPASMOMEN is and what it is used for

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

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

2. What you need to know before taking SPASMOMEN

Do not take SPASMOMEN
If you are allergic to the active substance (otilonium bromide) or to any of the other ingredients of
this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking SPASMOMEN.
Use SPASMOMEN 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
The use of Spasmomen is not recommended in patients under 18 years of age.

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

Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breast-feeding,
consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breast-feeding, take SPASMOMEN only if strictly necessary and under close medical supervision.

Driving and using machines
SPASMOMEN does not affect or affects negligibly the ability to drive or use machinery.

SPASMOMEN 40 mg film-coated tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

SPASMOMEN 40 mg film-coated tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take SPASMOMEN

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 film-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.
The tablets must be swallowed whole with a glass of water, preferably before meals.

Use in children and adolescents
The use of Spasmomen is not recommended in patients under 18 years of age.

Use in the elderly
No data are available.

Use in patients with liver or kidney problems
No data are available.

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

If you forget to take SPASMOMEN
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Tell your doctor or pharmacist if you notice any of the following side effects.
Uncommon (may affect up to 1 in 100 people):
Dry mouth
Nausea
Stomach pain or pain in the upper abdomen (upper abdominal pain)
Itchy skin
Skin redness (erythema)
Tiredness
Feeling weak
Headache
Dizziness (a sensation of spinning or loss of balance)
Not known (frequency cannot be estimated from the available data):
Allergic reactions, the signs of which may include itchy raised skin lesions ("urticaria"), localized subcutaneous swelling mainly affecting the face, lips, tongue or throat, with difficulty swallowing ("angioedema").
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website: 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 SPASMOMEN

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 SPASMOMEN contains
Each film-coated tablet contains:
Active substance: otilonium bromide 40 mg
Other components:
Core: monohydrate lactose, rice starch, sodium starch glycolate type A, magnesium stearate.
Coating: hypromellose, titanium dioxide, macrogol (polyethylene glycol 4000, polyethylene glycol 6000), talc.
Description of the appearance of SPASMOMEN and package contents
Film-coated tablets, round, biconvex, white or almost white.
Blister pack containing 30 film-coated tablets in a cardboard box.
Marketing Authorization Holder
A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - 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)