Package leaflet: Information for the user

OBISPAX 40 mg + 2 mg coated tablets

hyoscine butylbromide + diazepam
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 adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT OBISPAX IS AND WHAT IT IS USED FOR

OBISPAX contains the active substances otilonium bromide, a compound with spasmolytic action (i.e.,
it induces relaxation) on the smooth muscle of the gastrointestinal tract, and diazepam,
a benzodiazepine with anxiolytic properties (reduces anxiety).
OBISPAX is used in adults for the treatment of spastic-painful conditions (strong
muscle contractions associated with pain) of the gastroenteric system with an anxious component.

2. WHAT YOU SHOULD KNOW BEFORE TAKING OBISPAX

Do not take OBISPAX

If you are allergic to the active substances (otilonium bromide, diazepam) or to any of the other ingredients of this medicine (listed in section 6);
if you have glaucoma (increased internal pressure of the eye);
in case of prostatic hypertrophy (enlargement of the prostate);
in case of intestinal obstruction syndromes (arrest of intestinal content progression due to an obstacle or blockage) or urinary retention (inability of the bladder to expel urine);
in case of severe myasthenia (a disease characterized by muscle weakness).

The use of OBISPAX is contraindicated during the first trimester of pregnancy (see "Pregnancy and breastfeeding").
Furthermore, it is not recommended in early infancy (see "Children and adolescents").

Warnings and precautions
Talk to your doctor or pharmacist before taking OBISPAX.
If you take OBISPAX for a prolonged period, regular monitoring of blood parameters (blood tests) and liver function is advisable.
In predisposed individuals, treatment with benzodiazepines at high doses and for prolonged periods may lead to dependence, as occurs with other medicines having hypnotic (sleep-inducing), sedative (calming), and ataractic (tranquilizing) effects.
Since individual responsiveness (personal response to the drug) is highly variable, if you are elderly or debilitated, the dose of OBISPAX should be determined cautiously (see section 3 "How to take OBISPAX").

Children and adolescents
OBISPAX contains otilonium bromide and diazepam, a benzodiazepine with anxiolytic action.
The use of benzodiazepines in early infancy is generally not recommended (see "Do not take OBISPAX").

Other medicines and OBISPAX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of OBISPAX and other psychotropic drugs requires particular caution and medical supervision to avoid unexpected adverse interactions.
Use OBISPAX with caution when taken together with centrally-acting medicines (those acting on the central nervous system), such as neuroleptics (antipsychotic drugs used to treat certain psychiatric disorders such as schizophrenia, bipolar disorder, and some forms of depression), antidepressants, hypnotics (drugs that induce sleep), analgesics (reduce pain), and anesthetics (drugs capable of inducing temporary loss of pain sensation), as this combination may increase sedative effects.
The concomitant use of Obispax and opioids (substances used as strong painkillers, for substitution therapy in drug-dependent patients, and present in some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Obispax together with opioids, the dose and duration of concomitant treatment must be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow the doctor’s instructions regarding dosage. It may be helpful to inform family members and friends about how to recognize the above-mentioned signs and symptoms. If you experience such symptoms, consult your doctor immediately.

OBISPAX and alcohol
Do not consume alcoholic beverages during treatment with OBISPAX, as, similar to any other psychotropic medicine (affecting mental state), individual reactions cannot be predicted.

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

Pregnancy
Do not take OBISPAX during the first trimester of pregnancy (see "Do not take OBISPAX").
During the second and third trimesters of pregnancy, take OBISPAX only if clearly needed and when, in the doctor’s judgment, potential benefits outweigh possible risks.

Breastfeeding
If you are breastfeeding, take OBISPAX only if clearly needed and when, in the doctor’s judgment, potential benefits outweigh possible risks.

Driving and using machines
OBISPAX, like other medicines with the same mechanism of action, may affect your ability to drive and operate machinery.

3. HOW TO TAKE OBISPAX

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 1–3 tablets per day, according to the doctor's judgment, to be taken
preferably after meals.
However, the choice of the most appropriate dosage should be guided by the characteristics of the
fixed combination (oxyzolamine bromide + diazepam), and not by those of the individual components.
In elderly patients, the dosage must be carefully determined by the doctor, who should consider a
possible reduction of the above-mentioned doses (see "Warnings and precautions").
The duration of treatment may vary depending on the nature and severity of the disease, according to
the doctor's judgment.
If you take more OBISPAX than you should
In animals, oxyzolamine bromide has been shown to be practically devoid of toxicity. Consequently,
in humans, no particular problems due to overdose are expected.
Symptoms of diazepam overdose include drowsiness, confusion, coma, and reduced reflexes.
Although these effects are generally minimal, respiration, pulse (heart rate), and blood pressure
should be monitored, and general supportive measures should be implemented, along with
immediate gastric lavage (emptying of the stomach).
If you forget to take OBISPAX
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 ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur with the use of OBISPAX:

Rare adverse reactions:

ataxia (a disorder of muscle coordination making it difficult to perform certain movements);
headache;
nausea, vomiting, diarrhea, constipation, abdominal pain;
palpitations (increased awareness of heartbeat);
visual disturbances;
hypotension (low blood pressure);
dry mouth;
pruritus, skin rashes (appearance of red spots on the skin, more or less raised);
sialorrhea (excessive production of saliva);
depression, confusion, hallucinations;
cases of granulocytopenia (decreased concentration of granulocytes, a type of white blood cells, in the blood);
changes in blood levels (blood concentration) of transaminases (enzymes whose blood concentration indicates the presence of liver diseases), phosphatase (enzyme providing information on possible diseases of bones, liver, pancreas and intestine), and bilirubin (a colored substance present in bile derived from hemoglobin degradation);
irritability.

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

somnolence;
dizziness.

These adverse reactions are more frequent in elderly or debilitated patients.
If these are signs of relative overdose (a condition in which the drug is taken according to the recommended dosage, but due to the presence, for example, of liver or kidney diseases, its blood concentration increases), they resolve spontaneously within a few days or after adjusting the dosage.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the following website: http://www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE OBISPAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The
expiry date refers to the last day of that month and to the product in its original intact packaging,
properly stored.
This medicine does not require any special storage conditions.
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. PACK CONTENTS AND OTHER INFORMATION

What OBISPAX contains
Each coated tablet contains:
Active substances: otilonium bromide 40 mg, diazepam 2 mg.
Other components: microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch,
precipitated silica, magnesium stearate.
Coating: hypromellose, titanium dioxide, talc, macrogols, iron oxides.

Description of the appearance of OBISPAX and pack contents
Oval, pink-coated tablets with the letter "M" engraved on one side.
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 Sette Santi, 3 – Florence.
Berlin Chemie AG – Glienicker Weg, 125 - Berlin – Germany.
A.Menarini Manufacturing Logistics and Services s.r.l. – Campo di Pile – L’Aquila.