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 SUN Pharma 400 micrograms 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 SUN Pharma 400 micrograms prolonged-release hard capsules (called tamsulosin capsules throughout this leaflet) contains the active ingredient tamsulosin. This is a selective α1A/1D-adrenoceptor antagonist. It reduces tension of the smooth muscles in the prostate and the urethra, enabling urine to pass more readily through the urethra and facilitating urination. In addition, it diminishes sensations of urge. Tamsulosin capsules is used in men for the treatment of the complaints of the lower urinary tract associated with an enlarged prostatic gland (benign prostatic hyperplasia) These complaints may include difficulty urinating (poor stream), dribbling, urgency and having to urinate frequently at night as well as during the day. 2.
What you need to know before you take it
e tamsulosin capsules
Do not take tamsulosin capsules: if you are allergic to tamsulosin hydrochloride or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may present as sudden local swelling of the soft tissues of the body (e.g. the throat or tongue), difficult breathing and/or itching and rash (angioedema). if you suffer from severe liver problems. if you suffer from fainting due to reduced blood pressure when changing posture (going to sit or stand up) or you feel dizzy.
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Warnings and precautions Talk to your doctor or pharmacist before taking tamsulosin capsules . Periodic medical examinations are necessary to monitor the development of the condition you are being treated for. Before starting treatment you should tell your doctor if you are suffering from any other disease. Rarely, fainting can occur during the use of tamsulosin capsules as with other medicinal products of this type. At the first signs of dizziness or weakness you should sit or lie down until they have disappeared. if you suffer from severe kidney or liver problems, tell your doctor. if you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eye (glaucoma), please inform your eye specialist that you have previously used, are using, or are planning to use tamsulosin capsules can may cause complications (intraoperative Floppy Iris Syndrome [IFIS]) during the surgery. 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 a cataract- or glaucoma surgery because of a cloudy lens. 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. In particular tell your doctor or pharmacist if you are taking:
- Diclofenac (an anti-inflammatory painkiller) and warfarin (used to prevent blood clotting).
- Medicines to potentially influencing the blood level of tamsulosin such as verapamil or diltiazem (used to lower your blood pressure), ritonavir and indinavir (used to treat HIV infection), ketoconazole, itraconazole or erythromycin (used to treat fungal or bacterial infection). Taking Tamsulosin capsules together with other medicines from the same class (α1-adrenoceptor antagonists such as doxazosin, indoramin, prazosin or alfuzosin) may cause an unwanted decrease in blood pressure. It is especially important to inform your doctor if you are being treated at the same time with medicines that may decrease the removal of tamsulosin capsules from the body (for example, ketoconazole, erythromycin). You should only take medicine concomitantly with tamsulosin capsules if your doctor allows it. Tamsulosin capsules with food, drink and alcohol Tamsulosin capsules must be taken after breakfast or the first meal of the day.
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Pregnancy, breast-feeding and fertility This section is not relevant, because tamsulosin capsules is not indicated for use in women. Impaired sexual functions in males have been reported with tamsulosin capsules. Driving and using machines There is no evidence that tamsulosin capsules affects the ability to drive or to operate machinery or equipment. However, you should bear in mind that dizziness can occur, in which case you should not undertake activities that require attentiveness. Tamsulosin capsulescontains orange yellow S, azorubine and ponceau 4R Allergic reactions may occur due to the presence of colouring agents used in this product: orange yellow S (E110), azorubine (E122) and ponceau 4R (E124). Tamsulosin capsules contains sodium This medicine contains less than 1 mmol sodium (23 mg) per capsule, hard, that is to say essentially 'sodium-free'.
3.
How to take it
tamsulosin capsules
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The dosage is one capsule per day to be taken after breakfast or the first meal of each day. The capsule should be taken while standing or sitting (not lying down) with a glass of water. The capsule is to be swallowed whole and must not be crushed or chewed, as this would impair the delayed release of the active ingredient. Usually, tamsulosin capsules is prescribed for long periods of time. The effects on the bladder and on urination are maintained during longterm treatment with tamsulosin capsules. If you take more Tamsulosin capsules than you should Taking too many capsules of tamsulosin capsules may lead to an unwanted decrease in blood pressure and an increase in heart rate, with feelings of faintness. Contact your doctor immediately if you have taken too much tamsulosin capsules. If you forget to take tamsulosin capsules You may take your daily tamsulosin capsules later the same day if you have forgotten to take it as recommended. If you have missed a day, just continue to take your daily capsule as prescribed. Do not take a double dose to make up for a forgotten capsule. If you stop taking tamsulosin capsules When treatment with tamsulosin capsules is stopped prematurely, your original complaints may return. Therefore use tamsulosin capsules as long as your doctor prescribes, even if your complaints have disappeared already. Always consult your doctor, if you consider stopping this therapy. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects are rare or very rare. Stop taking this medicine and see a doctor straight away if you experience any of the following symptoms – you may need medical treatment:
- Sudden local swelling of soft tissues (e.g., throat or tongue), difficulty breathing, and/or itching and skin rash, often in the form of an allergic reaction (angioedema) (may affect up to 1 in 1,000 people)
- priapism (painful, persistent, involuntary erection of the penis), in which case immediate medical aid is needed (may affect up to 1 in 10,000 people)
- a severe inflammatory eruption of the skin and mucous membranes, which is an allergic reaction to drugs or other substances called Stevens-Johnson syndrome, (may affect up to 1 in 10,000 people)
- serious skin rashes (erythema multiforme, dermatitis exfoliative) (frequency cannot be estimated from the available data). The following side effects have also been reported: Common (may affect up to 1 in 10 people):
- Dizziness, particularly when going to sit or stand up.
- Ejaculation disorders
- Retrograde ejaculation; this means that semen does not leave the body via the urethra, but instead goes into the bladder. This phenomenon is harmless.
- Ejaculation failure. Uncommon (may affect up to 1 in 100 people):
- Headache
- palpitations (the heart beats more rapidly than normal and it is also noticeable)
- reduced blood pressure e.g. when getting up quickly from a seating or lying position sometimes
- associated with dizziness
- runny or blocked nose (rhinitis)
- diarrhoea, feeling sick and vomiting
- constipation, weakness (asthenia), rashes, itching and hives (urticaria). Rare (may affect up to 1 in 1000 people): fainting weakness Not known (frequency cannot be estimated based on available data)
- Vision blurred, visual impairment
- Nose bleed
- Dry mouth
- Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficult breathing (dyspnoea).
- If you are undergoing eye surgery because of cloudiness of the lens (cataract) and are already taking or have previously taken tamsulosin capsules , the pupil may dilate poorly
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and the iris (the coloured circular part of the eye) may become floppy during the procedure. If you have to undergo eye surgery due to a clouding of the lens (cataract) or increased intraocular pressure (glaucoma) and are taking or have recently taken tamsulosin capsules , insufficient dilation of the pupil and drooping of the iris (the colored circular part of the eye) may occur during surgery. 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 By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Tamsulosin capsules
Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions Do not use this medicine after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month. Never dispose of medicines in the wastewater (e.g. not in the toilet or sink). Ask your pharmacy how to dispose of the medicine when you are no longer using it. By doing so, you will help protect the environment. 6.
Contents of the pack and other information
What Tamsulosin capsules contains The active substance is tamsulosin hydrochloride. One prolonged release capsule contains 400 micrograms of tamsulosin hydrochloride. The other ingredients are: capsule contents: cellulose microcrystalline PH101, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion, sodium hydroxide, triacetin, titanium dioxide (E171), purified talc. Capsule body: gelatine, orange yellow S (E110), ponceau 4R (E124), quinoline yellow (E104), brilliant blue (E133), titanium dioxide (E171). Cap composition: gelatine, yellow iron oxide (E172), brilliant blue (E133), azorubine (E122), titanium dioxide (E171). Printing ink: shellac, black iron oxide (E172), potassium hydroxide. What Tamsulosin capsules looks like and contents of the pack
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Tamsulosin capsules comprise of light Brown cap/Orange body of size '2 ́ imprinted with 'R' on cap and ́TSN400' on body in black edible ink containing white to off-white granules. Packs of 1, 2, 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98,100 or 200 prolonged release capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer SUN PHARMA UK LIMITED 6-9 The Square, Stockley Park, Uxbridge, UB11 1FW United Kingdom Manufacturers Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 2132 JH Hoofddorp The Netherlands Terapia, S.A. 124, Fabricii Street, Zip Code 400632, Cluj Napoca, Cluj Romania This leaflet was last revised in November 2024.
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Frequently asked questions about Tamsulosin hydrochloride SUN Pharma 400 micrograms prolonged-release hard capsules
How do I take Tamsulosin hydrochloride SUN Pharma 400 micrograms prolonged-release hard capsules?
Tamsulosin hydrochloride SUN Pharma 400 micrograms 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 SUN Pharma 400 micrograms prolonged-release hard capsules?
The active substance in Tamsulosin hydrochloride SUN Pharma 400 micrograms prolonged-release hard capsules is tamsulosin hydrochloride.
Are there equivalent medicines to Tamsulosin hydrochloride SUN Pharma 400 micrograms 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 Zentiva 400 microgram 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 SUN Pharma 400 micrograms 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 SUN Pharma 400 micrograms 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
Oral use.
One capsule daily, to be taken after breakfast or the first meal of the day.
The capsule must be swallowed whole and should not be crunched or chewed, as this interferes with the modified release of the active ingredient.
Use in renal impairment
No dose adjustment is warranted in renal impairment.
Use in hepatic impairment
No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also 4.3).
Paediatric population
There is no relevant indication for use of this medicine product in children.
The safety and efficacy of tamsulosin in children < 18 years have not been established. Currently available data are described in section 5.1.
4.3. Contraindications
• Hypersensitivity to the active substance, including drug-induced angioedema, or to any of the excipients listed in section 6.1.
• A history of orthostatic hypotension.
• Severe hepatic insufficiency.
4.4. Special warnings and precautions for use
As with other α 1-adrenoceptors antagonists, a reduction in blood pressure can occur in individual cases during treatment with tamsulosin, 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 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.
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 cataract or glaucoma 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 (e.g. ketoconazole) in patients with poor metaboliser CYP2D6 phenotype.
Tamsulosin hydrochloride should be used with caution in combination with strong (e.g. ketoconazole) and moderate (e.g. erythromycin) inhibitors of CYP3A4 (see section 4.5).
Allergic reactions to the presence of colouring agents azorubine (E122), ponceau 4R (E124) and sunset yellow (E110) may occur.
Other ingredients
This medicinal product contains less than 1 mmol (23 mg) of sodium per capsule, which means it is nearly "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 (e.g. ketoconazole) in patients with poor metaboliser CYP2D6 phenotype.
Tamsulosin hydrochloride should be used with caution in combination with strong (e.g. ketoconazole) and moderate (e.g. erythromycin) 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.
There is a theoretical risk of enhanced hypotensive effect when given concurrently with drugs which may reduce blood pressure, including anaesthetic agents and other α1-adrenoceptor antagonists.
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 blurred vision, dizziness and syncope can occur.
4.8. Undesirable effects
The adverse reactions are described by frequency and system organ class (SOC) in the table below.
System Organ Class
Common
> 1/100, < 1/10
Uncommon
>1/1.000, < 1/100
Rare
> 1/10.000, < 1/1.000
Very rare
< 1/10.000
Not known
Nervous system disorders
Dizziness (1.3%)
Headache
Syncope
Eye disorders
Vision blurred*, visual impairment*
Cardiac disorders
Palpitations
Vascular disorders
orthostatic hypotension
Respiratory, thoracic and mediastinal disorders
Rhinitis
Epistaxis*
Gastrointestinal disorders
Constipation, diarrhoea, nausea vomiting
Dry mouth*
Skin and subcutaneous tissue disorders
rash, pruritus and urticaria
angioedema
Stevens-Johnson syndrome
Erythema multiforme*, Dermatitis exfoliative*
Reproductive system and breast disorders
Ejaculation disorders
Retrograde ejaculation, Ejaculation failure
priapism
General disorders and administration site conditions
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 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.
4.9. Overdose
Symptoms
Overdosage with tamsulosin hydrochloride can potentially result in severe hypotensive effects, dizziness and malaise. 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 can be 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 SUN Pharma 400 micrograms 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.