Patient leaflet - Terazosin 10 mg tablets
1. What Terazosin is and what it is used for
The name of this medicine is Terazosin 2 mg Tablets, Terazosin 5 mg Tablets or Terazosin 10 mg Tablets referred to as Terazosin throughout this leaflet.
Terazosin belongs to a group of medicines called ‘alpha blockers’ which help to relax smooth muscle and has been prescribed for you to treat one of the following:
- Treat mild to moderate hypertension (high blood pressure).
- Improve the obstructive symptoms caused by benign prostatic hyperplasia (BPH) and help the flow of urine from the bladder 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. Terazosin 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 Terazosin
Do not take Terazosin
if you are allergic to Terazosin or any of the other ingredients of this medicine listed in
Section 6 (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing).
- if you are allergic to any of the following drugs: alfuzosin, indoramin, prazosin, tamsulosin, doxazosin.
- if you have ever fallen over or fainted whilst passing water.
Do not take Terazosin if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Terazosin if you:
- Are taking other medication for high blood pressure. If a medicine for high blood pressure is started whilst you are taking Terazosin, your doctor may need to adjust your dose of Terazosin
- Have any problems with your heart
- Are taking medicines for erectile dysfunction (e.g. Cialis, Viagra, Levitra) • Are planning cataract removal surgery
- Terazosin can cause fainting or low blood pressure, usually after the first few doses. These effects can also occur if you stop taking Terazosin and then re-start. • Terazosin may also lead to decreases of certain laboratory values, such as red blood cells or white blood cells.
- Have any problems with your liver.
Terazosin must be used for BPH only after excluding other possible reasons in urinary tract for abnormal/ interrupted urinary flow.
If the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Terazosin.
Children and adolescents
Terazosin are not recommended for use in children.
Other medicines and Terazosin
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Please tell your doctor or pharmacist if you are taking any of the following:
- Antihypertensive drugs such as ACE inhibitors (lisinopril, captopril) to treat high blood pressure
- Diuretics (water tablets).
- Medicines for erectile dysfunction (e.g. Cialis, Viagra, Levitra, Stendra).
Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly.
The medicines which cause low blood pressure with alpha blockers include
- medicines treating high blood pressure – adrenergic neurone blockers (e.g. Guanethidine);
- alcohol;
- cancer treating medicine (e.g. aldesleukin);
- medicines for treating high blood pressure (e.g. Angiotensin – II receptor antagonists, Beta-blockers, Calcium-channel blockers, Clonidine, Moxonidine, Tizanidine Diazoxide, Hydralazine, Nitrates, Sodium nitroprusside;
- medicines for treating schizophrenia (antipsychotics);
- medicines for treating muscle spasm (e.g. baclofen);
- anti-inflammatory drugs like corticosteroids;
- medicines used for general anesthesia before surgery;
- medicine used for baldness (Minoxidil);
- medicines for treating Parkinson’s condition (e.g. levodopa and Methyldopa); • medicines for treating depression (MAO’s).
- medicine used for chest pain (nitrates)
- pain killers
- female sex hormone (estrogen)
Certain patients have experienced these symptoms when taking these symptoms when taking drugs for erectile dysfunction (impotence) with alpha-blockers. These medicines include alprostadil and Moxisylyte. In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha-blockers before you start drugs for erectile dysfunction.
If you are going to have a general anaesthetic, you should tell the doctor or dentist in charge that you are taking Terazosin Tablets.
If you are undergoing eye surgery because of cataracts (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used Terazosin. This is because Terazosin may cause complications during the surgery which can be managed if your specialist is prepared in advance.
Terazosin with food, drink and alcohol
Terazosin can be taken with or without food
Do not consume alcohol while on treatment with Terazosin as alcohol may increase the risk of dizziness, light- headedness or drowsiness.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Terazosin Tablets should not be used during pregnancy unless considered appropriate by your doctor. It is not known whether Terazosin passes into breast milk.
Driving and using machines
For the first 12 hours after starting therapy, or every time the dose is increased, you may experience dizziness, light -headedness or drowsiness. Therefore, it is very important that you do not drive or use any tools or machines if you are affected.
Terazosin contains lactose, sodium, quinoline yellow lake (E104), red iron oxide (E172) and Indigotine Lake (E132)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol (23mg) per tablet, that is to say essentially ‘sodium-free’. In addition, the 2 mg tablets contain quinoline yellow lake (E104), the 5 mg tablets contain red iron oxide (E172) and the 10 mg tablets contain indigotine lake (E132), which may cause allergic reactions.
3. How to take Terazosin
Always take Terazosin exactly as your doctor or pharmacist has told you. The doctor, depending on your needs and the condition being treated, will decide the dose of Terazosin. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
- Swallow the tablets whole with a drink of water.
How much to take – adults and the elderly (over 65 years of age)
- The usual starting dose is 1mg before bedtime. Therefore, if you are just starting therapy, your doctor will also have prescribed you a 1mg tablet from another company • Your doctor may slowly increase the amount you take until the right dose for you is found.
To treat BPH
- Your doctor may have to increase your dose every 1 or 2 weeks until the right dose is reached. The usual dose is 5 to 10mg taken once daily.
To treat high blood pressure
- Your doctor may have to increase your dose every week until the right dose is reached. The usual dose is 2 mg to 10 mg taken once daily
- If you start taking other medication for high blood pressure, your doctor may reduce your dose of Terazosin and gradually increase it again.
Children (less than 18 years of age)
Do not give to children less than 18 years of age.
If you take more Terazosin than you should
If you take more Terazosin than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. Signs of overdose include low blood pressure, dizziness, lightheadedness, fainting, a rapid or irregular heartbeat and feeling sick.
If you forget to take Terazosin
- If you forget a tablet, just take the next dose at the usual time.
- Do not take a double dose to make up for a forgotten dose.
- If you have not taken a tablet for several days, do not continue taking tablets, but see your doctor for advice on restarting therapy.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible Side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
Stop taking Terazosin and see a doctor or go to a hospital straight away, if you notice any of the following serious side effects – you may need urgent medical treatment:
- Severe allergic reactions – signs include skin rash, itching, swollen or lumpy skin, difficulty breathing, wheeziness, swelling of the face, lips, tongue or throat.
Side effects particularly at the beginning or re-start of treatment:
- Feeling dizzy, light-headed or faint if you stand up too quickly.
Fainting can occur after starting therapy, and occasionally after increasing the dose or adding other medication. If this happens, lie down again, and then sit for a few minutes before standing. Tell your doctor if this happens to you.
Not known: frequency cannot be estimated from the available data:
- Low blood platelet count;
- Weakness, dizziness;
- A fast or uneven heartbeat;
- Feeling sick;
- Swelling of the hands and feet;
- Asthenia (decrease in muscle strength);
- Sleepiness;
- Blocked nose;
- Blurred vision;
- Back pain, neck pain, shoulder pain, pains in hands and feet, pins and needles; • Headache;
- Chest pains;
- Low blood pressure (hypotension) which can cause dizziness or faintness on standing; • Loss of consciousness;
- Dilatation of blood vessels;
- Swelling, flushing, facial swelling;
- Weight gain;
- Nervousness, depression, anxiety;
- Shortness of breath or difficulty breathing;
- Decreased sex-drive, erectile dysfunction, persistent and painful erection; • Vertigo (problems with balance that can result in feelings of dizziness or sickness -particularly on standing);
- Flushing of the face;
- Stomach pain, indigestion;
- being sick, constipation, diarrhoea, wind;
- Dry mouth;
- Inflammation or pains in joints or muscles;
- Difficulty sleeping;
- Bronchitis (inflammation of the lungs);
- Sinusitis (inflammation of the nasal passage);
- Rhinitis (irritation and swelling of the mucous membrane in the nose); • Nose bleeds;
- Flu-like symptoms, pain and irritation of the throat, sore throat, cough; • Skin rashes and itching;
- Sweating;
- Vision problems and conjunctivitis;
- Ringing in the ears;
- Increased frequency of passing water, urinary infection, lack of bladder control; • Low blood cell counts, laboratory tests abnormal.
Some patients have experienced unexpected bruising and their blood taking longer than usual to clot after a cut to the skin.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 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 affects you help provide information on the safety of this medicine.
5. How to store Terazosin
- Keep out of the sight and reach of children
- Do not use Terazosin after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required which will help protect the environment.
- This medicine does not require any special storage conditions
6. Contents of the pack and other information
What Terazosin contains
- The drug substance is terazosin. The tablets come in three strengths containing 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochloride dihydrate
- The other ingredients are lactose monohydrate, croscarmellose sodium, cellactose 80, magnesium stearate (E572). In addition, the 2 mg tablets contain quinoline yellow lake (E104), the 5 mg tablets contain red iron oxide (E172) and the 10 mg tablets contain indigotine lake (E132).
What Terazosin Tablets look like and contents of the pack
Terazosin 2 mg Tablets are yellow, round, bevelled edged uncoated tablets, marked
‘S151’
Terazosin 5 mg Tablets are red, round, bevelled edged uncoated tablets, marked ‘S152’ • Terazosin 10 mg Tablets are blue, round, bevelled edged uncoated tablets, marked
‘S153’.
Terazosin is only available from your pharmacist on prescription in pack sizes of 28, 56 or 84 tablets. However, not all pack sizes may be marketed.
MA Holder: Steranco Healthcare UK Limited, John Eccles House, Robert Robinson Avenue, Oxford Science Park, Oxford, Oxfordshire, OX4 4GP, United Kingdom.
Manufacturer: Medley Pharma Limited, Unit 2A, Olympic Way, Sefton Business Park, Liverpool L30 1RD, UK