MICTONORM FORTE 45 mg PROLONGED-RELEASE CAPSULES

Introduction

Package Leaflet: Information for the User

Mictonorm Forte 45 mg Modified Release Capsules

Propiverine Hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Mictonorm Forte and what is it used for
2. What you need to know before you take Mictonorm Forte
3. How to take Mictonorm Forte
4. Possible side effects
5. Storage of Mictonorm Forte
6. Contents of the pack and further information

1. What is Mictonorm Forte and what is it used for

Mictonorm Forte is used to treat people who have difficulty controlling their bladder due to an overactive bladder. Mictonorm Forte contains the active substance propiverine hydrochloride. This substance prevents bladder contractions and increases bladder capacity. Mictonorm Forte is used to treat the symptoms of an overactive bladder. It comes in the form of modified-release capsules and is taken once a day.

2. What you need to know before you take Mictonorm Forte

Do not take Mictonorm Forte

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

Do not take Mictonorm Forte 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 functional loss of intestinal muscle capacity (intestinal atony)
• If you have severe intestinal inflammation (ulcerative colitis) that can cause diarrhea with blood and mucus and abdominal pain
• If you have toxic megacolon (a condition that leads to intestinal enlargement)
• If you have increased eye pressure (uncontrolled narrow-angle glaucoma)
• If you have severe liver disease
• If you have severe kidney problems
• If you have a rapid and irregular heartbeat

Warnings and Precautions

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

• nerve damage that affects blood pressure, heart rate, intestinal movements, and bladder function (autonomic neuropathy)
• kidney problems
• liver problems
• severe heart failure
• prostate enlargement
• recurrent urinary tract infections
• urinary tract tumors
• glaucoma
• heartburn and indigestion due to gastroesophageal reflux (hiatal hernia with esophageal reflux)
• irregular heartbeat
• rapid heartbeat

If you have any of these conditions, consult your doctor. He will indicate what you should do.

Other Medicines and Mictonorm Forte

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

• antidepressants (such as imipramine, clomipramine, and amitriptyline)
• sleeping pills (such as benzodiazepines)
• oral or injected anticholinergics (commonly used to treat asthma, stomach cramps, eye problems, or urinary incontinence)
• amantadine (a medicine used to treat influenza and Parkinson's disease)
• neuroleptics such as promazine, olanzapine, quetiapine (medicines used to treat psychotic disorders such as schizophrenia or anxiety)
• beta-stimulants (medicines used to treat asthma)
• cholinergics (e.g., drugs to reduce heart rate, stimulate digestion, and treat glaucoma, such as carbacol and pilocarpine)
• isoniazid (a medicine used to treat tuberculosis)
• metoclopramide (a medicine used to treat nausea and vomiting)
• concomitant treatment with methimazole (used to treat hyperthyroidism) and antifungal medications (e.g., ketoconazole, itraconazole).

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

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take other medicines, including those without a prescription.

Pregnancy, Breastfeeding, and Fertility

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

Driving and Using Machines

On some occasions, Mictonorm Forte may cause drowsiness and blurred vision. In this case, do not drive or operate hazardous machinery.

Mictonorm Forte contains Lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Mictonorm Forte

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

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

Use in children and adolescents: This medicine is not recommended for administration in 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 Forte than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the toxicology information service, phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Mictonorm Forte

Do not take a double dose to make up for forgotten doses. Continue treatment with the next dose at the usual time.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

You may experience an acute attack of glaucoma. In this case, you will notice colored rings around the light or severe pain in the eyes and around them. In this case, you should 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 people:

• discomfort and vomiting
• dizziness
• tremors
• inability to empty the bladder (urinary retention)
• flushing
• alteration of taste
• decrease in blood pressure with drowsiness
• tingling sensation
• difficulty urinating

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

• skin itching
• rapid heartbeat

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

• palpitations (increased intensity of heartbeats)
• agitation and confusion

Frequency not known: cannot be estimated from the available data:

• hallucinations
• language disorders

These side effects are transient and resolve when the dose is reduced or treatment is discontinued after 1-4 days.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mictonorm Forte

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 carton and blister after “EXP”. The expiry date is the last day of the month stated.

Do not store above 30°C. Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Mictonorm Forte

• The active substance is propiverine hydrochloride. Each modified-release capsule contains 45 mg of propiverine hydrochloride.
• The other ingredients (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), ammonio methacrylate copolymer type A, ammonio methacrylate copolymer type B, gelatin, titanium dioxide E171, red iron oxide E172, and yellow iron oxide E172

Appearance of the product and pack contents

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Manufacturer

APOGEPHA Arzneimittel GmbH

Kyffhäuserstraße 27

01309 Dresden (Germany)

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

• Spain: Mictonorm Forte 45 mg modified release capsules
• Northern Ireland: Aponorm XL 45 mg modified release capsules

This leaflet was approved in: April 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/