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.
TAMFREX XL 400 microgram 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 The active ingredient in TAMFREX XL is tamsulosin hydrochloride. It acts by relaxing the muscles in the prostate and urethra (the tube that carries urine to the outside), and lets urine pass more readily through the urethra and aids urination. In the prostate gland, bladder and urethra there are specialised cells containing alpha1Areceptors that cause the muscles in the urethra to tighten. TAMFREX XL is an alpha1Aadrenoceptor blocker, which reduces the action of these specialised cells and relaxes the muscles making it easier to pass water. TAMFREX XL is used to treat the symptoms associated with benign prostatic hyperplasia (BPH) which is enlargement of the prostate gland. These symptoms include difficulty in starting to pass water, frequent trips to the toilet to pass water, a feeling of not completely emptying the bladder and having to get up several times in the night to pass water.
What you need to know before you take it
e TAMFREX XL Do not use TAMFREX XL
- if you are allergic to tamsulosin hydrochloride or any of the other ingredients of TAMFREX XL (listed in section 6).
- if you suffer have a severe liver condition
- if you have ever fainted or felt dizzy when suddenly sitting or standing up. Dizziness can sometimes occur when taking TAMFREX XL, particularly if you are also taking other alpha1- blockers. If you do feel weak or dizzy make sure you sit or lie down straight away until the symptoms have disappeared. Warnings and precautions Talk to your doctor or pharmacist before taking TAMFREX XL.
- if you have kidney problems
- 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 TAMFREX XL. Black
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). Children and adolescents Do not give this medicine to children or adolescents under 18 years because it does not work in this population. Other medicines and TAMFREX XL Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because TAMFREX XL can affect the way that some other medicines work and some other medicines can affect the way that TAMFREX XL works. In particular tell your doctor or pharmacist if you are taking:
- Medicines to lower your blood pressure such as verapamil and diltiazem
- Medicines to treat HIV such as ritonavir or indinavir.
- Medicines to treat a fungal infection such as ketaconazole or itraconazole
- Other alpha blockers such as doxazosin, indoramin, prazosin or alfuzosin
- Erythromycin, an antibiotic used to treat infections Please inform your doctor that you are on TAMFREX XL before any operation or dental procedure as there is a potential that your medicine may interfere with the effects of the anaesthetic. Pregnancy, breast-feeding and fertility TAMFREX XL is not indicated for use in women. In men, abnormal ejaculation has been reported (ejaculation disorder). This means that the semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless. Driving and using machines There is no information available on whether TAMFREX XL affects the ability to drive or to operate machinery. However, it is known that TAMFREX XL may cause drowsiness, blurred vision, dizziness and fainting. If you suffer from these do not drive or operate machinery. TAMFREX XL contains Sodium This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.
How to take it
TAMFREX XL Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with doctor, pharmacist or nurse if you are not sure. The recommended dose for adults and the elderly is one capsule each day. It can be taken with or without food. Swallow the capsule whole. Do not crush or chew. Your doctor may want to examine you from time to time whilst you are taking this medicine. If you take more TAMFREX XL than you should If you have taken too many capsules, contact your doctor immediately or go to the nearest hospital casualty department taking any remaining medication and this patient information leaflet with you. If you forget to take TAMFREX XL You may take your capsule later the same day if you have forgotten to take it earlier. If you have missed a day, just continue to take your daily capsule from the next day. Do not take a double dose to make up for a missed dose.
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Package leaflet: Information for the user
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
which is stated on the carton or bottle after EXP. The expiry date refers to the last day of the month.
Possible side effects
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer use. These measures will help to protect the environment.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking this medicine and and consult your doctor immediately if any of the following occur – you may need medical treatment. Rare (affects less than 1 in 1000 people)
- Swelling of the face, throat or tongue with breathing problems linked to allergy Very rare (affects less than 1 in 10,000 people)
- Persistent painful erection usually unrelated to sexual activity.
- Rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).
- Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficult breathing (dyspnoea). The following side effects have also been reported: Common (affects less than 1 in 10 people)
- dizziness
- abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless. Uncommon (affects less than 1 in 100 people):
- weakness
- headache
- runny or blocked nose
- dizziness as you sit or stand up
- palpitations (rapid or irregular heart beat)
- gastro-intestinal symptoms such as nausea and vomiting (feeling or being sick), diarrhoea or constipation
- hypersensitivity reactions such as rash, itching, redness, local swelling and breathing problems Rare (affects less than 1 in 1000 people)
- fainting Not known (frequency cannot be estimated from the available data):
- blurred vision
- impaired vision
- nose bleeds (epistaxis)
- serious skin rashes (erythema multiform, dermatitis exfoliative)
- dry mouth As with other medicines of this type, drowsiness, blurred vision or swelling of the hands and feet can occur. 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
How to store it
TAMFREX XL
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. Do not use this medicine after the expiry date
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Keep this medicine out of the sight and reach of children.
Contents of the pack and other information
What TAMFREX XL contains The active substance is tamsulosin hydrochloride. Each prolonged-release capsule hard contains 0.4 mg of tamsulosin hydrochloride. –
The other ingredients are Capsule content: Cellulose microcrystalline, talc, methacrylic acid-ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, triacetin and calcium stearate. Capsule shell: Indigo carmine (E 132), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), sodium lauryl sulfate, gelatin. Printing Ink: Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide.
What TAMFREX XL looks like and contents of the pack Prolonged-release capsules, hard Olive green opaque/Orange opaque size '1EL' hard gelatin capsules imprinted with 'D' on cap and '53' on body with black edible ink. The capsules are filled with white to off-white beadlets. TAMFREX XL 400 microgram capsules are available in: PVC/PE/PVDC blister pack: 1, 2, 4, 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 200 hard, capsules. White opaque round HDPE bottle with white opaque polypropylene closure: 10 and 250 hard, capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom Manufacturer APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta or Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom This leaflet was last revised in 05/2023.
By reporting side effects you can help provide more information on the safety of this medicine.
Frequently asked questions about TAMFREX XL 400 microgram capsules
How do I take TAMFREX XL 400 microgram capsules?
TAMFREX XL 400 microgram 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 TAMFREX XL 400 microgram capsules?
The active substance in TAMFREX XL 400 microgram capsules is tamsulosin hydrochloride.
Are there equivalent medicines to TAMFREX XL 400 microgram capsules?
Medicines with the same active substance, strength and form include: Tabphyn MR 400 microgram modified-release capsules, hard, Tamsulosin hydrochloride SUN Pharma 400 micrograms prolonged-release hard capsules, 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 TAMFREX XL 400 microgram 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 TAMFREX XL 400 microgram 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
Tamsulosin is indicated in adults for the treatment of functional symptoms of benign prostatic hyperplasia (BPH).
4.2. Posology and method of administration
Posology
One capsule daily, to be taken with or without food.
No dose adjustment is warranted in renal impairment. No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also 4.3 Contraindications).
Paediatric population
The safety and efficacy of tamsulosin in children < 18 years have not been established. Currently available data are described in section 5.1.
Method of administration
For oral use.
The capsule should be swallowed whole and should not be crunched or chewed as this interferes with the prolonged release of the active ingredient.
4.3. Contraindications
Hypersensitivity to tamsulosin hydrochloride, 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-blockers, 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 severely renally impaired patients (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 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 (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)
4.5. Interaction with other medicinal products and other forms of interaction
No interactions have been seen when tamsulosin hydrochloride was given concomitantly with 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 changed.
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 (e.g. ketoconazole) and moderate inhibitors (e.g. erythromycin) 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 other drugs which may reduce blood pressure , including anaesthetic agents and other α 1-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 drowsiness, blurred vision, dizziness and syncope can occur.
4.8. Undesirable effects
System Organ Class
Common
(>1/100,to <1/10)
Uncommon
(>1/1 000, <1/100)
Rare
(≥ 1/10 000, <1/1 000)
Very rare
(<1/10 000)
Not known
(cannot be estimated from the available data)
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, urticaria
Angio-oedema
Stevens-Johnson syndrome
Erythema multiforme*, Dermatitis exfoliative*
Reproductive systems and breast disorders
Ejaculation disorders, Retrograde ejaculation, Ejaculation failure
Priapism
General disorders and administration site conditions
Asthenia
* Observed post-marketing.
As with other α blockers, drowsiness, blurred vision or oedema can occur.
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 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, 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 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 sulpfate, can be administered.
💬 Ask about this leaflet
Ask anything about TAMFREX XL 400 microgram 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.
Medicines containing Tamsulosin hydrochloride
- Flomaxtra XL, 400 micrograms, film-coated prolonged release tablet
- Tabphyn MR 400 microgram modified-release capsules, hard
- Tamsulosin hydrochloride SUN Pharma 400 micrograms prolonged-release hard capsules
- Tamsulosin hydrochloride Zentiva 400 microgram prolonged-release hard capsules
- Tamsulosin prolonged release tablets 400 microgram