Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Terazosin hydrochloride
Advanz Pharma
G04CA03
Terazosin hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050400; GTIN: 5060064170762
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Please keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you ONLY. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Hytrin Tablets are and what they are used for 2. What you need to know before you take Hytrin Tablets 3. How to use Hytrin Tablets 4. Possible Side Effects 5. How to Store Hytrin Tablets 6. Contents of the pack and other information 1. WHAT HYTRIN TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Hytrin 1 mg, 2 mg, 5 mg, or 10mg Tablets (called Hytrin Tablets in this leaflet). Hytrin Tablets contains the active ingredient terazosin. Terazosin belongs to a group of medicines called alpha-blockers. Hytrin Tablets are used in adults to treat high blood pressure. Hytrin Tablets are also used in adults for the treatment of a condition called benign prostatic hyperplasia (BPH) which affects the prostate and is common in older men. This condition stops the flow of urine from the bladder and can lead to symptoms such as a weak or interrupted urine flow, a need to pass water more frequently and/or a sudden need to pass water. Hytrin Tablets can relax the muscle of the prostate gland and bladder exit to help relieve these symptoms. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYTRIN TABLETS DO NOT TAKE HYTRIN TABLETS IF YOU: • are allergic to terazosin, or any of the following drugs: alfuzosin, indoramin, prazosin, tamsulosin, doxazosin, or to any of the other ingredients contained in this medicine listed in section 6 (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the fa Read the complete document
OBJECT 1 HYTRIN TABLETS 10MG Summary of Product Characteristics Updated 11-Oct-2018 | ADVANZ Pharma • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Hytrin 10 mg Tablets Terazosin 10 mg Tablets 2. Qualitative and quantitative composition Each tablet contains 10 mg of terazosin as monohydrochloride dihydrate. Excipients with known effect: Lactose (117.68 mg) For a full list of excipients, see section 6.1. 3. Pharmaceutical form Blue, round, flat bevelled tablets embossed with logo and triangular facets on one face and plain on the other. 4. Clinical particulars 4.1 Therapeutic indications Orally administered Hytrin is indicated in adults for the treatment of mild to moderate hypertension. It may be used in combination with thiazide diuretics and/or other antihypertensive drugs or as sole therapy where other agents are inappropriate or ineffective. The hypotensive effect is most pronounced on the diastolic pressure. Although the exact mechanism of the hypotensive action of Read the complete document