MictoNorm Forte 45 mg modified-release capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Mictonorm forte 45 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.
Leaflet contents
- What Mictonorm forte is and what it is used for
- What you need to know before taking Mictonorm forte
- How to take Mictonorm forte
- Possible side effects
- How to store Mictonorm forte
- Contents of the pack and other information
1. What Mictonorm forte is and what it is used for
Mictonorm forte is used for the treatment of 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 overactive bladder. It comes in modified-release capsules and is administered once daily.
2. What you need to know before taking Mictonorm forte
Do not take Mictonorm forte
Do not take Mictonorm forte 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 forte 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 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 eye pressure (uncontrolled narrow-angle glaucoma)
- If you have severe liver disease
- If you have severe kidney problems
- If you have a fast and irregular heart rate
Warnings and precautions
Before taking Mictonorm forte, 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
- Prostate enlargement
- 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 forte
You should inform your doctor if you are taking or have recently taken any of the following medicines, as they may interact with Mictonorm forte:
- Antidepressants (such as imipramine, clomipramine, and amitriptyline)
- Medicines for sleep (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 to treat psychotic disorders such as schizophrenia or anxiety)
- Beta-stimulants (medicines for the treatment of asthma)
- Cholinergics (e.g. drugs to reduce heart rate, stimulate digestion, or treat glaucoma, such as carbachol and pilocarpine)
- Isoniazid (a medicine for the treatment of tuberculosis)
- Metoclopramide (a medicine for the treatment of 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 forte well. Your doctor will decide what is most appropriate for you.
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those not requiring a prescription.
Pregnancy, breast-feeding and fertility
Do not take Mictonorm forte if you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant.
Driving and using machines
Mictonorm forte may occasionally cause drowsiness and blurred vision. If this occurs, do not drive or operate dangerous machinery.
Mictonorm forte contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him or her before taking this medicine.
3. How to take Mictonorm forte
Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.
Recommended dose:
Adults and elderly patients: The usual dose is one capsule daily.
Use in children and adolescents: Administration of this medicine 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 forte than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the toxicology information service at 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet 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 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 the following:
- 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 (urinary retention)
- 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:
- itching of the skin
- increased heart rate
Very rare adverse effects: may affect up to 1 in 10,000 patients:
- palpitations (increased intensity of heartbeats)
- agitation and confusion
Frequency not known: cannot be estimated from available data:
- hallucinations
- speech disturbances
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, although rarely, reversible hepatic alterations may 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 through 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 forte
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "CAD". The expiry date refers to the last day of the month indicated.
Do not store above 30°C. Keep 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 are unsure, 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 forte
- The active substance is propiverine hydrochloride. Each modified-release capsule contains 45 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 contents of the pack
The capsules are orange in colour and contain white or almost white granules. They are supplied in blisters and packs containing 7, 14, 20, 28, 30, 49, 50, 56, 60, 84, 98, 100, 112 or 280 capsules.
Only some pack sizes may be commercially available.
Marketing Authorization Holder
LACER, S.A. - Boters, 5
08290 Cerdanyola del Vallès
Barcelona – Spain
Manufacturer
APOGEPHA Arzneimittel GmbH
Kyffhäuserstraße 27
01309 Dresden (Germany)
This medicinal product is authorized 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 medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/