Leaflet: information for the user

Mictonorm 30 mg modified-release capsules

propiverina hydrochloride

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet (see section 4).

Your medicine is called Mictonorm 30 mg modified-release capsules (Mictonorm in this leaflet). The active ingredient is propiverina hydrochloride and the rest of the components are listed at the end of this leaflet (see section 6, Contents of the pack and additional information)

Mictonorm is used to treat individuals who have difficulty controlling their bladder due to overactive bladder. Mictonorm contains the active ingredient propiverine hydrochloride. This substance prevents bladder contraction and increases bladder capacity. Mictonorm is used to treat symptoms of overactive bladder. It is presented in the form of modified-release capsules and is administered once a day.

Do not take Mictonorm

Do not take Mictonorm if you are allergic (hypersensitive) to propiverine hydrochloride or any of the other components of this medication (listed in section 6).

Do not take Mictonorm if you have any of the following conditions:

• If you have intestinal obstruction
• If you have urinary tract obstruction (difficulty urinating)
• If you have severe myasthenia (excessive muscle weakness)
• If you have a functional loss of intestinal muscle capacity (intestinal atony)
• If you have severe intestinal inflammation (ulcerative colitis) that may cause diarrhea with blood and mucus and abdominal pain
• If you have toxic megacolon (a disorder that causes intestinal elongation)
• If you have uncontrolled closed-angle glaucoma (increased eye pressure)
• If you have severe liver disease
• If you have a rapid and irregular heart rhythm

Warnings and precautions

Before taking Mictonorm, inform your doctor if you have or have had any medical problems such as:

• Nerve damage controlling blood pressure, heart rate, intestinal movements, and bladder functions (autonomic neuropathy)
• Renal problems
• Hepatic problems
• Severe heart failure
• Prostate hypertrophy
• Recurrent urinary tract infections
• Urinary tract tumors
• Glaucoma
• Heartburn and indigestion due to gastroesophageal reflux (hiatal hernia with esophageal reflux)
• Irregular heart rhythm
• Increased heart rate

If you have any of these conditions, consult your doctor. They will tell you what to do.

Other medications and Mictonorm

You should inform your doctor if you are taking or have taken the following medications, as they may interact with Mictonorm.

• Antidepressants (such as imipramine, clomipramine, and amitriptyline)
• Sleeping medications (such as benzodiazepines)
• Oral or injected anticholinergics (used for asthma, stomach cramps, eye problems, or urinary incontinence)
• Amantadine (medication used for flu and Parkinson's disease treatment)
• Neuroleptics such as promazine, olanzapine, and quetiapine (medications for treating psychotic disorders such as schizophrenia or anxiety)
• Beta-stimulants (medications for asthma treatment)
• Cholinergics (such as carbacol and pilocarpine)
• Isoniazid (medication for tuberculosis treatment)
• Metoclopramide (medication for nausea and vomiting treatment)
• Concomitant treatment with methimazole (used for treating hyperthyroidism) and medications for fungal infections (e.g., ketoconazole, itraconazole).

However, you may be fine taking Mictonorm. Your doctor will decide what is best for you.

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including over-the-counter medications.

Pregnancy, breastfeeding, and fertility

Do not take Mictonorm if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant.

Driving and operating machinery

Mictonorm may cause drowsiness and blurred vision in some cases. Do not drive or operate hazardous machinery.

Mictonorm contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

The recommended dose is:

Adults and elderly: The usual dose is one capsule per day.

Use in children and adolescents: Mictonorm is not recommended for children.

Method of administration:

Take your capsule at the same time every day. Swallow the capsule whole with a glass of water. Do not crush or chew the capsules. It can be taken with or without food.

If you take more Mictonorm than you should

If you have taken more Mictonorm than you should, consult your doctor or pharmacist immediately, or call the toxicology information service, phone 91 562 04 20 indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Mictonorm

Do not take a double dose to compensate for the missed doses. Continue treatment with the next dose at your usual time.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

All medicines can cause allergic reactions, although severe allergic reactions are very rare. The immediate symptoms of these reactions are as follows:

• any sudden reaction with wheezing, difficulty breathing, or dizziness, swelling of eyelids, face, lips, or throat
• peeling and blisters on the skin, mouth, eyes, and genitals
• generalized body rash

If you experience any of these symptoms during treatment, you must interrupt it and contact your doctor immediately.

You may suffer an acute attack of glaucoma. In this case, you will observe rings of color around the light or severe pain in the eyes and around them. In this case, you must contact your doctor immediately.

The following side effects have been reported:

Very common side effects:may affect more than 1 in 10 people:

• dry mouth

Common side effects:may affect up to 1 in 10 people:

• abnormal vision and difficulty focusing
• fatigue
• headache
• abdominal pain
• indigestion
• constipation

Uncommon side effects:may affect up to 1 in 100 patients:

• unpleasantness and vomiting
• dizziness
• tremors
• inability to empty the bladder
• flushing of the face
• alteration of taste
• drop in blood pressure with drowsiness
• sensation of tingling
• difficulty urinating

Rare side effects:may affect up to 1 in 1,000 patients:

• skin itching
• acceleration of heartbeats

Very rare side effects:may affect up to 1 in 10,000 patients

• palpitations (increase in intensity of heartbeats)
• agitation and confusion

Unknown frequency:cannot be estimated from the known data:

• hallucinations
• language alterations

These side effects are transient and resolve after reducing the dose or discontinuing treatment within 1-4 days.

During long-term administration, liver enzymes should be monitored, as, although rarely, reversible liver changes may be observed.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not store above 86°F (30°C). Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Mictonorm

• The active ingredient is propiverine hydrochloride. Each modified-release capsule contains 30 mg of propiverine hydrochloride.
• The other components (excipients) are: citric acid, povidone, lactose monohydrate, talc, triethyl citrate, magnesium stearate, methacrylic acid-methyl methacrylate copolymer (1:1), methacrylic acid-methyl methacrylate copolymer (1:2), ammonium methacrylate copolymer type A, ammonium methacrylate copolymer type B, gelatin, titanium dioxide E171, iron oxide red E172, and iron oxide yellow E172.

Appearance of the product and content of the container

The capsules are orange and white containing white or off-white granules. They are presented in blisters and in containers with 7, 14, 20, 28, 30, 49, 50, 56, 60, 84, 98, 100, 112, or 280 capsules.

Only some container sizes may be commercially available.

Holder of the marketing authorization

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Responsible for manufacturing

APOGEPHA Arzneimittel GmbH

Kyffhäuserstraße 27

01309 Dresden (Germany)

This medicine is authorized in the EEA under the following names:

• Spain: Mictonorm 30 mg modified-release capsules
• Northern Ireland: Aponorm XL 30 mg modified-release capsules

This leaflet has been approved in: October 2021

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