Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Doralese Tiltab Tablets 20 mg
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Indoramin hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Doralese Tiltab Tablets (called 'Doralese' in this leaflet) contain a medicine called indoramin (as indoramin hydrochloride). This belongs to a group of medicines called 'alpha-blockers' (also called alpha adrenoceptor antagonists). What Doralese is used for
- Doralese is used to treat a condition where your prostate becomes bigger, called 'benign prostatic hyperplasia' or BPH. The prostate is a gland found underneath the bladder in men. It surrounds the tube (called the urethra) which carries urine from the bladder to the outside of the body.
- if the prostate gland becomes bigger, it may squeeze on the urethra and make it hard for you to pass urine. When your prostate grows:
- the flow of your urine may be weaker or you may have to pass urine more often than before
- this can happen during the day or you can find you have to get up more often during the night
- you may have to wait for the flow of your urine to start
- you may find it difficult to stop the flow of your urine completely
- as men get older their prostate grows in size and some men will suffer these symptoms
- Doralese can be used for patients who do not need or want an operation and also for patients waiting for an operation. How Doralese works
- Doralese relaxes muscles in your bladder, prostate gland and the tube that carries urine from the bladder to the outside of the body
- this will help your urine flow better.
What you need to know before you take it
e Doralese
Do not take Doralese
- if you are allergic to indoramin or any of the ingredients of Doralese (listed in section 6)
- if you have heart failure. 89/L/x/3
Warnings and precautions Talk to your doctor or pharmacist before taking Doralese:
- if you have liver or kidney problems
- if you have Parkinson's disease
- if you have epilepsy
- if you have ever had depression. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Doralese. You may need to be given another medicine or your dose may need to be lowered. Other medicines and Doralese Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Doralese can affect the way some other medicines work. Also some other medicines can affect the way Doralese works. In particular tell your doctor or pharmacist if you are taking any of the following medicines:
- Monoamine oxidase inhibitors, sometimes called 'MAOls', used for depression. Do not take Doralese if you are already taking a MAOI
- medicines used for high blood pressure such as water tablets (diuretics) or beta-blockers
- medicines that can lower blood pressure such as water tablets (diuretics), moxisylytes (medicines used for circulation problems) and medicines used for depression, anxiety or to help you sleep
- medicines that may make you sleepy such as pain killers, antidepressants, tablets for your nerves and antihistamines. Cataract eye surgery patients If you are due to have eye surgery because of a cataract (cloudiness of the lens):
- Tell your eye specialist before the operation that you are using or have previously used Doralese.
- Doralese and other medicines of the same type (alpha-blockers) may cause problems during the surgery which can be managed if your specialist is told before your operation. Doralese with alcohol Do not drink alcohol if Doralese makes you feel drowsy. Alcohol can increase the amount of Doralese that gets from your stomach into your blood stream. This could make you feel more drowsy. Pregnancy and breast-feeding Occasionally a doctor may prescribe Doralese for a woman. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Driving and using machines You may feel sleepy while taking Doralese. If this happens, do not drive or use any tools or machines. If you feel very sleepy, tell your doctor. Doralese contains lactose (a type of sugar) If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take it
Doralese
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. How much to take
- The usual dose is one tablet (20 mg) twice a day.
- The tablet should be swallowed with water.
- Some elderly patients may need just one tablet at night. 89/L/x/3
- Your doctor may increase your dose to a maximum total daily dose of 100 mg.
- Do not take more than your doctor has recommended. If you take more Doralese than you should
- If you take more Doralese than you should, contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose have included deep sedation leading to coma, irregular heartbeat, changes to your heartbeat (these symptoms can have potentially serious, lifethreatening consequences), abnormally low blood pressure and fits. If you forget to take Doralese
- If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
- Do not take a double dose to make up for a forgotten dose. If you stop taking Doralese
- Do not stop taking Doralese without talking to your doctor. If you stop taking your tablets, your symptoms may come back. 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 following side effects may happen with this medicine:
- when you start taking Doralese you may feel sleepy. This will usually go after a few days
- other less common side effects include dry mouth, stuffy nose, weight gain, dizziness, failure to ejaculate, depression, headache and dizziness caused by low blood pressure, which can occur on standing. The dizziness may or may not be accompanied by fainting. Rare (affects less than 1 in 1,000 people)
- allergic (hypersensitivity) reactions, such as a rash and itching
- Parkinson's disease may get worse. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
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.
How to store it
Doralese • • • •
Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Store below 25°C. 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.
Contents of the pack and other information
What Doralese contains
- The active substance is indoramin (as indoramin hydrochloride).
- Each film-coated tablet contains 20 mg of indoramin. 89/L/x/3
•
The other ingredients are lactose monohydrate, magnesium stearate, microcrystalline cellulose and Amberlite IRP 88. The film-coating is made of Opadry OY- 3736 and purified water. The polish contains: carnauba wax.
What Doralese looks like and contents of the pack
- Doralese Tiltab are pale yellow, triangular film-coated tablets bearing a raised kite shape on each face. The special 'Tiltab' design helps you to pick up your tablets more easily.
- They are available in blister packs of 60 tablets. Marketing Authorisation Holder Chemidex Pharma Ltd, Chemidex House, 8a Crabtree Road, Egham, Surrey, TW20 8RN, United Kingdom. Manufacturer Lelypharma B.V., Zuiveringweg 42, 8243 PZ Lelystad, the Netherlands. This leaflet was last revised in July 2024 'Doralese', 'Chemidex' and the Chemidex logo are trademarks of Chemidex Pharma Ltd. 'Tiltab' is a trademark of, and used under licence from, the GlaxoSmithKline group of companies.
89/L/x/3
Frequently asked questions about Doralese Tiltab Tablets 20 mg
How do I take Doralese Tiltab Tablets 20 mg?
Doralese Tiltab Tablets 20 mg comes as tablet containing 20mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Doralese Tiltab Tablets 20 mg?
The active substance in Doralese Tiltab Tablets 20 mg is indoramin hydrochloride.
Are there equivalent medicines to Doralese Tiltab Tablets 20 mg?
Medicines with the same active substance, strength and form include: Indoramin 20 mg Tablet, Indoramin 20 mg film-coated tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Doralese Tiltab Tablets 20 mg, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Doralese Tiltab Tablets 20 mg without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: indoramin hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Conditions for which alpha blockade is indicated.
Management of urinary outflow obstruction due to benign prostatic hyperplasia.
4.2. Posology and method of administration
Posology
Hyperplasia
Adults:
20 mg twice daily.
Dosage may be increased in 20 mg increments at two-weekly intervals up to max. 100 mg per day if required.
Elderly:
20 mg at night may be adequate.
Paediatric population: Not recommended.
Method of administration
For oral administration.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Patients with established heart failure.
Patients already under treatment with a monoamine oxidase inhibitor.
4.4. Special warnings and precautions for use
Incipient cardiac failure should be controlled before treatment with indoramin.
Caution should be observed in prescribing indoramin for patients with hepatic or renal insufficiency.
A few cases of extrapyramidal disorders have been reported in patients treated with indoramin. Caution should be observed in prescribing indoramin in patients with Parkinson's disease.
In animals and in the one reported case of overdose in humans, convulsions have occurred. Due consideration should be given, and great caution exercised in the use of indoramin in patients with epilepsy.
The 'Intraoperative Floppy Iris Syndrome (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural complications during the cataract operation current or part use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.
Caution should be observed in prescribing indoramin for patients with a history of depression.
Clearance of indoramin may be affected in the elderly. A reduced dose, and/or reduced frequency of dosing may be sufficient in some elderly patients.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
Do not use indoramin in patients being treated with a monoamine oxidase (MAO) inhibitor.
Concomitant use of indoramin with antihypertensive drugs or drugs with hypotensive properties e.g. antidepressants, anxiolytics, hypnotics and moxisylyte, may enhance their hypotensive action. Titration of dosage of the latter may therefore be needed.
Alcohol can increase both the rate and extent of absorption of indoramin, but no untoward effects have been reported at recommended doses.
4.6. Fertility, pregnancy and lactation
Pregnancy
Animal experiments indicate no teratogenic effects but indoramin tablets should not be prescribed for pregnant women unless considered essential by the physician.
Breast-feeding
There are no data available on the excretion of indoramin in human milk, but the drug should not be administered during lactation unless in the judgement of the physician such administration is clinically justifiable.
4.7. Effects on ability to drive and use machines
Drowsiness is sometimes seen in the initial stages of treatment with indoramin or when dosage is increased too rapidly. If drowsiness occurs, patients should be warned not to drive or operate machinery and to avoid CNS depressants including alcohol.
4.8. Undesirable effects
Drowsiness or sedation can occur on starting treatment with indoramin, and also if dosage is increased too rapidly. Less commonly, dry mouth, nasal congestion, weight gain, dizziness, failure of ejaculation, depression, fatigue, headache and hypotension (including postural hypotension) with or without syncope may occur.
Rarely, Parkinson's disease could be exacerbated.
Rarely, hypersensitivity reactions including rash and pruritus may occur.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
Information available at present of the effects of acute overdosage in human beings with indoramin is limited. Effects seen have included deep sedation leading to coma, hypotension and fits. Results of animal work suggest that hypothermia may also occur.
Suggested therapy is along the following lines:
1. Recent ingestion of large numbers of tablets would require gastric lavage or a dose of ipecacuanha to remove any of the product still in the stomach of the conscious patient.
2. Ventilation should be monitored and assisted if necessary.
3. Circulation support and control of hypotension should be maintained.
4. If convulsions occur diazepam may be tried.
Temperature should be closely monitored. If hypothermia occurs, rewarming should be carried out very slowly to avoid possible convulsions.
💬 Ask about this leaflet
Ask anything about Doralese Tiltab Tablets 20 mg. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.