Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
for 2. What you need to know before you take TabphynTM MR 400 microgram Capsules 3. How to take TabphynTM MR 400 microgram Capsules 4. Possible side-effects 5. How to store TabphynTM MR 400 microgram Capsules 6. Contents of the pack and other information
1.What TabphynTM MR 400 microgram Capsules are and what they are used for Tamsulosin is an α adrenoreceptor blocker. It relaxes the muscles in the prostate and urinary tract. Tamsulosin is prescribed to alleviate urinary symptoms caused by an enlarged prostrate (benign prostatic hyperplasia). By relaxing the muscle it enables urine to be passed more easily and helps urination. 1A
e TabphynTM MR 400 microgram Capsules DO NOT take TabphynTM MR 400 microgram Capsules if you:
Other medicines and TabphynTM MR 400 microgram Capsules Other medicines may be affected by tamsulosin. They, in turn, may affect how well tamsulosin works. Tamsulosin can interact with:
TabphynTM MR 400 microgram Capsules Always take this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure. The recommended dose is one capsule per day taken after breakfast or after your first meal of the day. Swallow the capsule whole with a glass of water, while standing or sitting (not while lying down). It is important that you do not break or crush the capsule as this may influence how well TabphynTM MR 400 microgram Capsules work.
9279578 2508 GB
If you take more TabphynTM MR 400 microgram Capsules than you should Your blood pressure may suddenly drop if you take more TabphynTM MR 400 microgram Capsules than you should. You may experience dizziness, weakness and fainting. Lie down to minimise the effects of low blood pressure and then contact your doctor. Your doctor may give you medicines to restore your blood pressure and monitor your body function. When necessary your doctor may empty your stomach and give you a laxative to remove any tamsulosin not yet taken up in the blood from your body. If you forget to take TabphynTM MR 400 microgram Capsules Do not take a double dose to make up for a forgotten dose. Just take the next dose at the usual time. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side-effects, although not everybody gets them. Common (may affect up to 1 in 10 people):
TabphynTM MR 400 microgram 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 packaging after 'EXP'. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month. Store the blisters in the original package in order to protect from moisture. Keep the container tightly closed in order to protect from moisture. 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.
What TabphynTM MR 400 microgram Capsules contain
Cod. 0846/I
Tabphyn MR 400 microgram modified-release capsules, hard 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.
The active substance in Tabphyn MR 400 microgram modified-release capsules, hard is tamsulosin hydrochloride.
Medicines with the same active substance, strength and form include: TAMFREX XL 400 microgram capsules, 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.
This leaflet reproduces the patient information leaflet approved for Tabphyn MR 400 microgram modified-release capsules, hard, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
One capsule a day after breakfast or the first meal of the day. The capsule is swallowed whole with a glass of water while standing or sitting (not lying down). The capsule should not be broken or pulled apart as this may have an effect on the release of the long-acting active ingredient.
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.
• Hypersensitivity to the active substance, including drug-induced angio-oedema, or to any of the excipients listed in section 6.1.
• A history of orthostatic hypotension.
• Severe hepatic insufficiency.
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.
The patient should be examined before commencement of therapy with tamsulosin to exclude the presence of other conditions that can produce similar symptoms to those of BPH. The prostate should be examined via the rectum and, if necessary, the PSA count determined prior to commencement of treatment and again later at regular intervals.
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.
Angioedema has been rarely reported after the use of tamsulosin. 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, cataract 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).
Excipients
This medicinal product contains less than 1 mmol sodium (23mg) per capsule, that is to say essentially 'sodium free'.
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, chlormadinone, 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-adrenoreceptor antagonists could lead to hypotensive effects.
Tabphyn™ MR 400 microgram 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 authorisation phase.
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.
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)
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
Angioedema
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
-
-
During cataract or glaucoma surgery a small pupil situation, known as Intraoperative Floppy Iris Syndrome (IFIS), has been associated with therapy of tamsulosin during post-marketing surveillance (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 website: www.mhra.gov.uk/yellowcard or search for 'MHRA Yellow Card' in the Google Play or Apple App Store.
Symptoms:
Acute overdose with 5mg tamsulosin hydrochloride has been reported. Acute hypotension (systolic blood pressure 70mmHg), vomiting and diarrhoea were observed, which were treated with fluid replacement and the patient could be discharged the same day.
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 anything about Tabphyn MR 400 microgram modified-release capsules, hard. 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.
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