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.
Tamsulosin hydrochloride Zentiva 400 microgram prolonged-release hard capsules
⚠ 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 Tamsulosin 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 Tamsulosin hydrochloride Zentiva 400 microgram prolonged-release hard capsules (called tamsulosin capsules throughout this leaflet) contains the active substance tamsulosin, which reduces the tension in muscles of the prostate and urethra. Thus an easier flow of urine through the urethra and subsequently easier urination are facilitated. Tamsulosin capsules are used in men for the treatment of difficulties associated with benign enlargement of the prostate such as: difficult urination, urinary dribbling, strong urge to urination, frequent urination during the night as well as during the day.
What you need to know before you take it
e tamsulosin capsules
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. If dizziness or weakness occurs, it is necessary to sit down or lay down until disappearance of these signs. Discontinue use of this product and seek immediate medical assistance if you get: − Hypersensitivity reaction with purplish spots or patches on the skin, blisters on the skin, peeling of the skin, (high) fever, joint pain and/or eye inflammation (Stevens-Johnson syndrome).* − Serious allergic reaction which causes swelling of the face or throat (angioedema).** The side effects which may occur are listed below in groups according to the frequency: − Common (may affect up to 1 in 10 people): Dizziness (can occur especially on an abrupt alteration of the position – when sitting up or standing up from the lying position), difficulties with ejaculation, little or no semen ejaculated at sexual climax, cloudy urine following sexual climax. − Uncommon (may affect up to 1 in 100 people): Headaches, feeling your heartbeat (palpitations), light-headedness or fainting (orthostatic hypotension), swelling and irritation inside the nose (rhinitis), constipation, diarrhoea, feeling sick (nausea), vomiting, rash, itching, hives (urticaria), feeling of weakness (asthenia). − Rare (may affect up to 1 in 1,000 people): Short-term loss of consciousness (syncope), angioedema**. − Very rare (may affect up to 1 in 10,000 people): Painful long-lasting unwanted erection which requires immediate medical assistance (priapism), Stevens-Johnson syndrome*. − Not known (frequency cannot be estimated from the available data): Disturbances of vision, blurred vision, bleeding from the nose (epistaxis), rash with red irregular spots (erythema multiforme), erythema and scaling of the skin (dermatitis exfoliative), abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficult breathing (dyspnoea), dry mouth. During eye surgery (cataract or glaucoma) a condition called Floppy Iris Syndrome (IFIS) may occur: The pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during surgery. For more information see section 2. Reporting of side effects If you get any side effects talk to your doctor or pharmacist. This includes any possible
How to take it
tamsulosin capsules Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one capsule a day. Take tamsulosin capsules after breakfast or after the first daily meal. Swallow whole, while sitting or standing, and follow with a glass of water. Do not open, crush or chew. If you take more tamsulosin capsules than you should Drop in blood pressure can occur after overdosage. Blood pressure and heart rate will return to normal by lying the patient down. If you take more tamsulosin capsules than you should, or in case of an accidental ingestion of the product by a child, immediately seek your doctor's advice. If you forget to take tamsulosin capsules If you have forgotten to take tamsulosin capsules at the scheduled time, take it anytime later during the day. If you realize this fact only on the next day, continue with the usual dosage scheme. Do not take a double dose to make up for a forgotten capsule. If you stop taking tamsulosin capsules Do not stop taking without medical advice from your doctor. If you have any further question on the use of this medicine, ask your doctor or pharmacist.
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Do not take tamsulosin capsules − if you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). − if angioedema (swelling due to allergic reaction) occurs after using of some drugs. − if you suffer from a serious infection of the liver. − if you suffer from dizziness when you want to sit up or stand up from the lying position. Warnings and precautions Talk to your doctor or pharmacist before taking tamsulosin capsules. On long-term use of this product regular medical examinations are necessary. Infrequently, drop in blood pressure has been reported during the use of the product tamsulosin capsules. On first feeling of dizziness, it is necessary to sit down or lay down until disappearance of these signs. Caution should be paid if you have severely impaired renal function as there is not sufficient data from clinical studies about patients with severe renal impairment. Angioedema (swelling due to allergic reaction) has been rarely reported after the use of tamsulosin. In case of angioedema seek immediate medical assistance and discontinue use of tamsulosin capsules. The product should not be re-administered. If you are planning to undergo cataract or glaucoma surgery, please inform your doctor that you are taking or have recently taken tamsulosin capsules. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens (cataract) or increased pressure in the eye (glaucoma). Caution should be exercised if you have already had malaise while you urinate or after urinating (micturition syncope). Children and adolescents Do not give this medicine to children or adolescent under 18 years because it does not work in this population. Other medicines and tamsulosin capsules Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Other medicines may be affected by tamsulosin. They, in turn, may affect how well tamsulosin works. Tamsulosin can interact with: − diclofenac, a pain killer and anti-inflammatory medicine. This medicine can speed up the removal of tamsulosin from your body, thereby shortening the time tamsulosin is effective. − warfarin, a medicine to prevent blood clotting. This medicine can speed up the removal of tamsulosin from your body, thereby shortening the time tamsulosin is effective. − another α1A-adrenoceptor blocker. The combination may lower your blood pressure, causing dizziness or light-headedness. − medicines that may decrease the removal of tamsulosin capsules from the body (for example, ketoconazole, erythromycin). Tamsulosin capsules with food and drink Take tamsulosin capsules after breakfast or after the first daily meal. Swallow whole, while sitting or standing, and follow with a glass of water. Do not open, crush or chew. Pregnancy, breast-feeding and fertility Pregnancy and breast-feeding Tamsulosin capsules are designed only for the treatment of men therefore information on pregnancy and breast-feeding is not relevant. Fertility Difficulties with ejaculation have been reported in association with tamsulosin use (see section 4). Driving and using machines Dizziness can occur during the treatment. Therefore activities requiring enhanced alertness should be performed only if allowed by the doctor. Important information about some of the ingredients of tamsulosin capsules This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium free'.
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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
tamsulosin capsules 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 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 tamsulosin capsules contain The active substance is tamsulosin hydrochloride at an amount of 400 microgram in each capsule (equivalent to 367 microgram of tamsulosin). The other ingredients are: Capsule content: Cellulose microcrystalline; metacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30% (contains sodium laurilsulfate, polysorbate 80); dibutyl sebacate; silica, colloidal hydrous; polysorbate 80; calcium stearate. Capsule shell: Gelatin; titanium dioxide (E171); yellow iron oxide (E172); red iron oxide (E172); black iron oxide (E172); indigotine – FD&C Blue2 (E132). What tamsulosin capsules look like and contents of the pack Tamsulosin capsules are hard gelatin capsules, no. 3 with orange body and olive cap containing white to off-white pellets. Each package contains 10, 20, 30, 50, 90 or 100 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder Zentiva Pharma UK Limited, 12 New Fetter Lane, London EC4A 1JP, United Kingdom Manufacturer Zentiva, S.A. 50 Theodor Pallady Blvd., District 3, Bucharest, 032266 Romania This leaflet was last revised in May 2024
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Frequently asked questions about Tamsulosin hydrochloride Zentiva 400 microgram prolonged-release hard capsules
How do I take Tamsulosin hydrochloride Zentiva 400 microgram prolonged-release hard capsules?
Tamsulosin hydrochloride Zentiva 400 microgram prolonged-release hard capsules comes as capsule containing 400mcg. 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 Tamsulosin hydrochloride Zentiva 400 microgram prolonged-release hard capsules?
The active substance in Tamsulosin hydrochloride Zentiva 400 microgram prolonged-release hard capsules is tamsulosin hydrochloride.
Are there equivalent medicines to Tamsulosin hydrochloride Zentiva 400 microgram prolonged-release hard capsules?
Medicines with the same active substance, strength and form include: TAMFREX XL 400 microgram capsules, Tabphyn MR 400 microgram modified-release capsules, hard, Tamsulosin hydrochloride SUN Pharma 400 micrograms prolonged-release hard capsules. 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 Tamsulosin hydrochloride Zentiva 400 microgram prolonged-release hard capsules, 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 Tamsulosin hydrochloride Zentiva 400 microgram prolonged-release hard capsules 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: tamsulosin 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
Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
4.2. Posology and method of administration
Posology
One capsule daily after breakfast or after the first daily meal.
Hepatic/renal impairment
No dose adjustment is warranted in renal impairment.
No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see section 4.3).
Paediatric population
The safety and efficacy of tamsulosin hydrochloride in children < 18 years have not been established. Currently available data are described in section 5.1.
Method of administration
Oral use.
The capsule is swallowed whole, without crushing or chewing, because otherwise the controlled release of the active ingredient would be affected.
4.3. Contraindications
• Hypersensitivity to the active substance including drug-induced angioedema or to any of the excipients listed in section 6.1.
• History of orthostatic hypotension.
• Severe hepatic insufficiency.
4.4. Special warnings and precautions for use
As with other α1-adrenoceptors antagonists, a reduction in blood pressure can occur in individual cases during treatment with tamsulosin hydrochloride as a result of which, rarely, syncope can occur. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the symptoms have disappeared.
Before therapy with tamsulosin hydrochloride is initiated, the patient should be examined in order to exclude the presence of other conditions, which can cause the same symptoms as benign prostatic hyperplasia. Digital rectal examination and, when necessary, determination of prostate specific antigen (PSA) should be performed before treatment and at regular intervals afterwards.
The treatment of patients with severe renal impairment (creatinine clearance of < 10 ml/min) should be approached with caution, as these patients have not been studied.
Angioedema has been rarely reported after the use of tamsulosin. In case of angioedema, treatment should be discontinued immediately, the patient should be monitored until disappearance of the oedema, and tamsulosin should not be re-administered.
The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract and glaucoma surgery in some patients on or previously treated with tamsulosin hydrochloride. IFIS may increase the risk of eye complications during and after the operation. Discontinuing tamsulosin hydrochloride 1 – 2 weeks prior to cataract or glaucoma surgery is anecdotally considered helpful, but the benefit of treatment discontinuation has not yet been established. IFIS has also been reported in patients who had discontinued tamsulosin for a longer period prior to the surgery. .
The initiation of therapy with tamsulosin hydrochloride in patients for whom cataract or glaucoma surgery is scheduled is not recommended. During pre-operative assessment, surgeons and ophthalmic teams should consider whether patients scheduled for cataract or glaucoma surgery are being or have been treated with tamsulosin in order to ensure that appropriate measures will be in place to manage the IFIS during surgery.
Tamsulosin hydrochloride should not be given in combination with strong inhibitors of CYP3A4 in patients with poor metaboliser CYP2D6 phenotype.
Tamsulosin hydrochloride should be used with caution in combination with strong and moderate inhibitors of CYP3A4 (see section 4.5).
Caution should be exercised in the treatment of patients with micturition syncope history
Excipient
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults.
No interactions have been seen when tamsulosin hydrochloride was given concomitantly with either atenolol, enalapril or theophylline. Concomitant cimetidine brings about a rise in plasma levels of tamsulosin, whereas furosemide a fall, but as levels remain within the normal range posology need not be adjusted.
In vitro, neither diazepam nor propranolol, trichlormethiazide, chlormadinon, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin change the free fraction of tamsulosin in human plasma. Neither does tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinon.
Diclofenac and warfarin, however, may increase the elimination rate of tamsulosin.
Concomitant administration of tamsulosin hydrochloride with strong inhibitors of CYP3A4 may lead to increased exposure to tamsulosin hydrochloride. Concomitant administration with ketoconazole (a known strong CYP3A4 inhibitor) resulted in an increase in AUC and Cmax of tamsulosin hydrochloride by a factor of 2.8 and 2.2, respectively.
Tamsulosin hydrochloride should not be given in combination with strong inhibitors of CYP3A4 in patients with poor metaboliser CYP2D6 phenotype.
Tamsulosin hydrochloride should be used with caution in combination with strong and moderate inhibitors of CYP3A4.
Concomitant administration of tamsulosin hydrochloride with paroxetine, a strong inhibitor of CYP2D6, resulted in a Cmax and AUC of tamsulosin that had increased by a factor of 1.3 and 1.6, respectively, but these increases are not considered clinically relevant.
Concurrent administration of other α1-adrenoceptor antagonists could lead to hypotensive effects.
4.6. Fertility, pregnancy and lactation
Tamsulosin is not indicated for use in women.
Ejaculation disorders have been observed in short and long term clinical studies with tamsulosin. Events of ejaculation disorder, retrograde ejaculation and ejaculation failure have been reported in the post authorization phase.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, patients should be aware of the fact that dizziness can occur.
4.8. Undesirable effects
Tabulated list of adverse reactions
The frequency of adverse reactions of tamsulosin listed below is defined using the following convention: Common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
MedDRA system organ class
Frequency
Adverse reaction
Nervous system disorders
Common
Dizziness (1.3%)
Uncommon
Headache
Rare
Syncope
Eye disorders
Not known
Vision blurred*, visual impairment*
Cardiac disorders
Uncommon
Palpitations
Vascular disorders
Uncommon
Orthostatic hypotension
Respiratory, thoracic and mediastinal disorders
Uncommon
Rhinitis
Not known
Epistaxis*
Gastrointestinal disorders
Uncommon
Constipation, diarrhoea, nausea, vomiting
Not known
Dry mouth*
Skin and subcutaneous tissue disorders
Uncommon
Rash, pruritus, urticaria
Rare
Angioedema
Very rare
Stevens-Johnson syndrome
Not known
Erythema multiforme*,
dermatitis exfoliative*
Reproductive system and breast disorders
Common
Ejaculation disorder,
retrograde ejaculation,
ejaculation failure
Very rare
Priapism
General disorders and administration site conditions
Uncommon
Asthenia
* Observed post-marketing.
During cataract and glaucoma surgery a small pupil situation, known as Intraoperative Floppy Iris Syndrome (IFIS), has been associated with therapy of tamsulosin during post-marketing surveillance (see also section 4.4).
Post-marketing experience: In addition to the adverse events listed above, atrial fibrillation, arrhythmia, tachycardia and dyspnoea have been reported in association with tamsulosin hydrochloride use. Because these spontaneously reported events are from the worldwide post marketing experience, the frequency of events and the role of tamsulosin in their causation cannot be reliably determined.
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
Symptoms
Overdosage with tamsulosin hydrochloride can potentially result in severe hypotensive effects. Severe hypotensive effects have been observed at different levels of overdosing.
Treatment
In case of acute hypotension occurring after overdosage cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders and, when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as tamsulosin is very highly bound to plasma proteins.
Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.
💬 Ask about this leaflet
Ask anything about Tamsulosin hydrochloride Zentiva 400 microgram prolonged-release hard capsules. 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.