MictoNorm 30 mg modified-release capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Mictonorm 30 mg modified release capsules
propiverine hydrochloride
Read the entire 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 should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Your medicine is called Mictonorm 30 mg modified release capsules (Mictonorm in this leaflet). The active substance is propiverine hydrochloride and the other components are listed at the end of this leaflet (section 6, Contents of the container and further information).
Leaflet contents:
- What Mictonorm is and what it is used for
- What you need to know before taking Mictonorm
- How to take Mictonorm
- Possible side effects
- How to store Mictonorm
- Contents of the container and further information
1. What Mictonorm is and what it is used for
Mictonorm is used for the treatment of people who have difficulty controlling their bladder due to an overactive bladder. Mictonorm contains the active substance propiverine hydrochloride. This substance prevents bladder contractions and increases bladder capacity. Mictonorm is used to treat the symptoms of overactive bladder. It is available in modified-release capsules and is administered once daily.
2. What you need to know before taking Mictonorm
Do not take Mictonorm
Do not take Mictonorm if you are allergic (hypersensitive) to propiverine hydrochloride or to any of the other ingredients of this medicine (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 passing urine)
- If you have myasthenia gravis (excessive muscle weakness)
- If you have a functional loss of intestinal muscle capacity (intestinal atony)
- If you have severe inflammation of the intestine (ulcerative colitis), which may cause diarrhoea with blood and mucus, and abdominal pain
- If you have toxic megacolon (a disorder causing intestinal dilation)
- If you have increased intraocular pressure (uncontrolled narrow-angle glaucoma)
- If you have severe liver disease
- If you have a fast and irregular heart rate
Warnings and precautions
Before taking Mictonorm, you must inform your doctor if you have or have had any medical problems such as:
- Nerve damage affecting blood pressure, heart rate, intestinal and bladder movements, and other bodily functions (autonomic neuropathy)
- Kidney problems
- Liver problems
- Severe heart failure
- Enlarged prostate (prostatic hypertrophy)
- Recurrent urinary tract infections
- Tumour of the urinary tract
- Glaucoma
- Heartburn and indigestion due to gastric reflux (hiatus hernia with oesophageal reflux)
- Irregular heart rhythm
- Increased heart rate
If you have any of these conditions, consult your doctor. He or she will advise you on what to do.
Other medicines and Mictonorm
You should inform your doctor if you are taking or have recently taken any of the following medicines, as they may interact with Mictonorm:
- Antidepressants (such as imipramine, clomipramine, and amitriptyline)
- Sleeping medications (such as benzodiazepines)
- Oral or injectable anticholinergics (commonly used to treat asthma, stomach cramps, eye conditions, 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-agonists (medicines used to treat asthma)
- Cholinergics (such as carbachol 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 overactive thyroid gland) and antifungal medicines (e.g. ketoconazole, itraconazole)
However, you may still tolerate Mictonorm well. Your doctor will decide what is most appropriate for you.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription.
Pregnancy, breast-feeding, and fertility
Do not take Mictonorm if you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant.
Driving and use of machines
Mictonorm may occasionally cause drowsiness and blurred vision. If this occurs, do not drive or operate dangerous machinery.
Mictonorm contains lactose
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him or her before taking this medicine.
3. How to take Mictonorm
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Recommended dose:
Adults and elderly: The usual dose is one capsule daily.
Use in children and adolescents: The administration of Mictonorm is not recommended in children.
Method of administration:
Take your capsule at the same time each 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, contact your doctor or pharmacist immediately, or call the toxicology information service at 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you forget to take Mictonorm
Do not take a double dose to make up for missed doses. Continue your treatment with the next dose at your usual time.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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
- skin peeling and blisters in the skin, mouth, eyes, and genitals
- widespread skin rash
If you experience any of these symptoms during treatment, you must stop taking the medicine and contact your doctor immediately.
You may experience an acute attack of glaucoma. In this case, you will notice colored halos around lights or severe eye pain and pain around the eyes. In such a case, you must contact your doctor immediately.
The following adverse effects have been reported:
Very common adverse effects: may affect more than 1 in 10 people:
- dry mouth
Common adverse effects: may affect up to 1 in 10 people:
- abnormal vision and difficulty focusing
- fatigue
- headache
- abdominal pain
- indigestion
- constipation
Uncommon adverse effects: may affect up to 1 in 100 patients:
- malaise and vomiting
- dizziness
- tremors
- inability to empty the bladder
- facial flushing
- taste disturbances
- drop in blood pressure with drowsiness
- tingling sensation
- difficulty urinating
Rare adverse effects: may affect up to 1 in 1,000 patients:
- skin itching
- increased heart rate
Very rare adverse effects: may affect up to 1 in 10,000 patients:
- palpitations (increased intensity of heartbeat)
- agitation and confusion
Frequency not known: cannot be estimated from available data:
- hallucinations
- speech disorders
These adverse effects are transient in nature and resolve upon dose reduction or discontinuation of treatment within 1–4 days.
During long-term administration, liver enzymes should be monitored, as reversible hepatic alterations may rarely occur.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Mictonorm
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month indicated.
Do not store above 30°C. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Mictonorm
- The active substance 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 medicine and contents of the pack
The capsules are orange and white and contain white or almost white granules. They are available in blisters and in packs containing 7, 14, 20, 28, 30, 49, 50, 56, 60, 84, 98, 100, 112 or 280 capsules.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
LACER, S.A. - Boters, 5
08290 Cerdanyola del Vallès
Barcelona – Spain
Manufacturer
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 was approved in: October 2021
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/