Patient leaflet - Darifenacin Aristo 7.5 mg prolonged-release tablets
1. What Darifenacin Aristo is and what it is used for
How Darifenacin Aristo works
Darifenacin Aristo reduces the activity of an overactive bladder. This enables you to wait longer before you go to the toilet and it increases the amount of urine that your bladder can hold.
What Darifenacin Aristo can be used for
Darifenacin Aristo belongs to a class of medicines which relax the muscles of the bladder. It is used in adults for the treatment of the symptoms of overactive bladder conditions - such as a sudden urge to rush to the toilet, needing to go to the toilet frequently and/or not getting to the toilet in time and wetting yourself (urge incontinence).
2. What you need to know before you take Darifenacin Aristo
Do not take Darifenacin Aristo:
- if you are allergic to darifenacin or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from urinary retention (inability to empty your bladder).
- if you have gastric retention (problems emptying the contents of the stomach).
- if you suffer from uncontrolled narrow-angle glaucoma (high pressure in the eyes that is not being adequately treated).
- if you have myasthenia gravis (a disease marked by unusual tiredness and weakness of selected muscles).
- if you have severe ulcerative colitis or toxic megacolon (acute dilation of the colon due to complication of infection or inflammation).
- if you have severe liver problems.
- if you are taking medicines that strongly decrease the activity of some liver enzymes such as ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis), verapamil (a medicine used to lower blood pressure, to correct heart rhythm or to treat angina pectoris), antifungal medicines (e.g. ketoconazole and itraconazole) and some antiviral medicines (e.g. ritonavir - see paragraph “Other medicines and Darifenacin Aristo”.
Warnings and precautions:
Talk to your doctor before taking Darifenacin Aristo:
- if you have autonomic neuropathy (damage to the nerves that communicate between the brain and internal organs, muscles, skin, and blood vessels to regulate vital functions, including the heart rate, blood pressure and bowel function) – your doctor will have told you if you have this.
- if you have a condition where one or more organs in your abdomen has moved up into your chest through a hole in your diaphragm, causing you to get heartburn and belch a lot.
- if you have difficulties in passing urine and a weak stream of urine.
- if you have severe constipation (less than or equal to 2 bowel movements per week).
- if you have a digestive motility disorder.
if you have an obstructive gastrointestinal disorder (any obstruction of the passage of intestinal or gastric contents, such as narrowing of the pylorus, the lower part of the stomach) – your doctor will have told you if you have this.
- if you are taking medicines that can cause or worsen inflammation of the oesophagus such as oral bisphosphonates (a class of medicines that prevent the loss of bone mass and are used to treat osteoporosis).
- if you are receiving treatment for narrow-angle glaucoma.
- if you have liver problems.
- if you have a urinary tract infection or other kidney problems.
- if you have an overactive muscle that controls the emptying of the bladder which may cause accidental passing of urine (a condition called detrusor hyperreflexia) - your doctor will tell you if you are suffering from this condition.
- if you have heart disease.
If any of these apply to you, tell your doctor before you take Darifenacin Aristo.
During treatment with Darifenacin Aristo, tell your doctor straight away and stop taking Darifenacin Aristo if you experience swelling of the face, lips, tongue and/or throat (signs of angioedema).
Children and adolescents
Darifenacin Aristo is not recommended for use in children and adolescents (<18 years).
Other medicines and Darifenacin Aristo
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
This is particularly important if you are taking any of the following as your doctor may need to adjust your dose of Darifenacin Aristo and/or the other medicine:
- certain antibiotics (e.g. erythromycin, clarithromycin, telithromycin and rifampicin),
- antifungal medicines (e.g. ketoconazole and itraconazole - see paragraph “Do not take Darifenacin Aristo”, fluconazole, terbinafine),
- medicines used to reduce the activity of the immune system, for example, after organ transplantation (e.g. ciclosporin – see paragraph “Do not take Darifenacin Aristo”,
- antiviral medicines (e.g. ritonavir - see paragraph “Do not take Darifenacin Aristo”),
- antipsychotic medicines (e.g. thioridazine),
- certain antidepressants (e.g. imipramine and paroxetine),
- certain anticonvulsants (carbamazepine, barbiturates),
- certain medicines used to treat heart problems (e.g.verapamil - see paragraph “Do not take Darifenacin Aristo”, flecainide, digoxin and quinidine),
- certain medicines used for the treatment of stomach problems (e.g. cimetidine),
- other antimuscarinic medicines (e.g. tolterodine, oxybutynin and flavoxate).
Please also inform your doctor if you are taking products containing St John’s wort.
Darifenacin Aristo with food and drink
Eating food has no effect on Darifenacin Aristo. Grapefruit juice may interact with Darifenacin Aristo. Tell your doctor if you are taking grapefruit juice regularly.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Darifenacin Aristo is not recommended during pregnancy.
Darifenacin Aristo should be taken with caution while breast-feeding.
Driving and using machines
Darifenacin Aristo may cause effects such as dizziness, blurred vision, trouble sleeping or drowsiness. If you have any of these symptoms whilst taking Darifenacin Aristo, consult your doctor for advice on changing the dose or considering an alternative treatment. You should not drive or use machines if you are affected by these symptoms. For darifenacin, these side effects have been reported to be uncommon (see section 4).
Package leaflet: Information for the patient
Darifenacin Aristo 7.5 mg prolonged-release tablets Darifenacin
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. Do not pass it on to others. It may harm them, even if their symptoms 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.
3. How to take Darifenacin Aristo
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. If you have the impression that the effect of Darifenacin Aristo is too strong or too weak, talk to your doctor or pharmacist.
How much Darifenacin Aristo to take
The recommended starting dose, including for patients aged over 65 years, is 7.5 mg daily. Depending on your response to Darifenacin Aristo, your doctor may increase your dose to 15 mg daily, two weeks after starting therapy.
These doses are suitable for people with mild liver problems or people with kidney problems.
Take Darifenacin Aristo tablets once a day with liquid, at about the same time each day.
The tablet may be taken with or without food. Swallow the tablet whole. Do not chew, split or crush it.
If you take more Darifenacin Aristo than you should
If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, go to your doctor or hospital for advice immediately. When seeking medical advice, make sure that you take this leaflet and your remaining tablets with you to show them to the doctor. People who have taken an overdose may have dry mouth, constipation, headache, indigestion and nasal dryness. Overdose with Darifenacin Aristo may lead to severe symptoms requiring emergency treatment in hospital.
If you forget to take Darifenacin Aristo
If you forget to take Darifenacin Aristo at the usual time, take it as soon as you remember, unless it is the time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Darifenacin Aristo
Your doctor will tell you how long your treatment with Darifenacin Aristo will last. Do not stop treatment early because you do not see an immediate effect. Your bladder will need some time to adapt. Finish the course of treatment prescribed by your doctor. If you have not noticed any effect by then, discuss it with your doctor.
If you have any further questions on 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.
The side effects caused by Darifenacin Aristo are usually mild and temporary.
Some side effects could be serious
Not known (frequency cannot be estimated from the available data)
Serious allergic reactions including swelling, mainly of the face and neck (angioedema).
Other side effects
Very common (may affect more than 1 in 10 people)
Dry mouth, constipation.
Common (may affect up to 1 in 10 people)
Headache, abdominal pain, indigestion, feeling sick, dry eyes, nasal dryness.
Uncommon (may affect up to 1 in 100 people)
Fatigue, accidental injury, facial swelling, high blood pressure, diarrhoea, flatulence, ulceration of the mucous membrane of the mouth, increased liver enzymes (this shows abnormal functioning of the liver), swelling including swelling of the hands, ankles or feet, dizziness, sleeplessness, drowsiness, abnormal thinking, runny nose (rhinitis), cough, shortness of breath, dry skin, itching, rash, sweating, visual disturbance including blurred vision, taste disturbance, urinary tract disorder or infection, impotence, discharge and itching in the vagina, bladder pain, inability to empty your bladder.
Not known (frequency cannot be estimated from the available data)
Confusion, depressed mood/mood altered, hallucination, muscle spasms.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Darifenacin Aristo
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. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Darifenacin Aristo contains
- The active substance is darifenacin. Each prolonged-release tablet contains 7.5 mg of darifenacin (as hydrobromide)
The other ingredients are:
Tablet core: Calcium hydrogen phosphate (E341(ii)), hypromellose (E464), magnesium stearate (E470b)
Film-coating: Hypromellose (E464), titanium dioxide (E171), macrogol, talc (E553b).
What Darifenacin Aristo looks like and contents of the pack
Darifenacin Aristo 7.5 mg prolonged-release tablets are white to almost white, round, biconvex, film-coated tablets embossed with “7.5” on one side with a diameter of 8 mm.
Darifenacin Aristo is available in blister packs containing 14, 28, 49 or 98 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany
Manufacturer
Medinsa (Laboratorios Medicamentos Internacionales, S.A.)
C/ Solana, 26,
28850 Torrejón de Ardoz, Madrid
Spain
This leaflet was last revised in 11/2025.
GI752000-05/UK/1125 50018915/2