Package Insert: Information for the Patient

Otilonio Qualigen 40 mg Film-Coated Tablets

Otilonium bromide

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See Section 4.

OtilonioQualigen contains the active ingredient otilonio bromide, which belongs to a group of medications that act by reducing intestinal contractions.

Otilonio is used for the treatment of spasms and alterations in gastrointestinalmotilityin adults.

Do not take Otilonio Qualigen:

• if you are allergic to otilonium bromide or to any of the other ingredients of this medication (listed in section 6).
• if you have intestinal obstruction.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Otilonio Qualigen if:

• You are taking several medications and/or are an elderly patient.
• You have glaucoma (increased pressure in the eye).
• You have benign prostatic hyperplasia (enlargement of the prostate).
• You have pyloric stenosis (difficulty in the passage of stomach contents to the intestine).
• You have liver or kidney problems.
• You have heart problems such as tachycardia (increased heart rate).
• You have hyperthyroidism (alteration of the thyroid gland with increased thyroid hormones).
• You have ulcerative colitis (inflammatory disease of the intestine).
• You have gastroesophageal reflux (passage of stomach contents to the esophagus).

Children

Do not use this medication in children and adolescents.

Elderly patients

Elderly patients should take this medication with caution.

Taking Otilonio Qualigen with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of otilonium use during pregnancy and breastfeeding has not yet been established.

Driving and operating machinery

Otilonio does not interfere with the ability to drive vehicles or operate machinery.

Important information about some of the components of Otilonio Qualigen

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet (40 mg of bromide of otilonio) taken two or three times a day, as prescribed by your doctor.

Administration Form:

The tablets are administered orally.

The tablets should be taken approximately 20 minutes before meals with half a glass of water.

The maximum duration of treatment is 4 weeks.

If the painful symptoms reappear, your doctor should evaluate the need to initiate a new treatment.

If You Take More Otilonio Qualigen Than You Should

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service. Phone: 915620420, indicating the medication and the amount ingested.

If You Forget to Take Otilonio Qualigen

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Adverse effects of unknown frequency (cannot be estimated from available data):

• Headache
• Nausea, vomiting, stomach pain,
• Urticaria
• Dizziness
• Fatigue

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it ispossible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Usewww.notificaRAM.es. By reporting adverse effects, you can contribute toproviding more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after“CAD”.The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and unused medications.By doing so, you will help protect the environment..

Composition of Otilonio Qualigen

• The active ingredient isotilonio bromide. Eachtabletcontains40mgofotiloniobromide
• The other components are:microcrystalline cellulose, pregelatinized cornstarch, sodium carboxymethyl starch (type A), glycerol diesterate, and dimethicone.
• The coating is hypromellose, macrogol 6000, titanium dioxide, and talc.

Appearance of the product and contents of the packaging

OtilonioQualigen is presented in the form of coated tablets. The tablets areround and white in color.

It is presented inPVC/aluminumblister packscontaining 60 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holderofthemarketingauthorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsibleformanufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970, Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet:June 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/