URIZIDE BENDROFLUMETHIAZIDE TABLETS 5 MG - patient leaflet, side effects, dosage

Package leaflet: Information for the User

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – 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 signs of illness are 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 Urizide is and what it is used for

• 2. What you need to know before you take Urizide

• 3. How to take Urizide

• 4. Possible side effects

• 5. How to store Urizide

• 6. Contents of the pack and other information

1. what urizide is and what it is used for

• Urizide tablets contains the active substance bendroflumethiazide which belongs to a group of medicines called thiazide diuretics (water tablets). They may be used to:
• reduce fluid retention (oedema) particularly in the heart, kidneys, liver or that caused by medication, by increasing the flow of urine
• reduce high blood pressure alone or with other medication.

2. what you need to know before you take urizide

Do not take Urizide Tablets if you:

• are allergic to bendroflumethi­azide, to thiazides or to any of the other ingredients of this medicine (listed in section 6)
• have severely impaired liver or kidney function
• have low blood levels of potassium which has not responded to treatment (refractory hypokalaemia)
• have low blood levels of sodium (hyponatraemia)
• have high blood levels of calcium (hypercalcaemia)
• have or have had gout (high levels of uric acid in the blood), causing crystals to deposit in joints of hands or feet causing pain (hyperuricaemia)
• have Addison’s disease (syndrome due to low level of corticosteroid hormones secretion, symptoms include weakness, loss of energy, low blood pressure and dark pigmentation of the skin).

Warnings and Precautions

• or may have diabetes. If you are taking insulin, your doctor may need to adjust your insulin dosage

• have systemic lupus erythematosus (SLE) (an inflammatory disease of connective tissue causing large areas of red scaly patches on the face, hair loss, weight loss, painful joints

and fever)

• experienced a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking Urizide. This can lead to permanent vision loss, if not treated. If you have a penicillin or sulphonamide allergy, you can be at higher risk of developing this
• hypokalaemia (low levels of potassium in blood)
• hyponatraemia (low levels of sodium in blood)
• hypomagnesaemia (low levels of magnesium in blood)
• hypercalcaemia (increased levels of calcium in blood)
• elevated plasma lithium concentration and risk of toxicity
• photosensitivity (itchy eruptions, redness and inflammation on patches of skin)
• pancreatitis (inflammation of the pancreas)
• gout (sudden swelling and severe pain in your joints)
• heart disease or arrhythmias (heart rhythm problems)
• been taking, or are taking, lithium. Talk to your doctor if you experience side effects such as tremor, confusion or have difficulty balancing, walking, speaking, swallowing, seeing or performing tasks that require a high degree of control, such as writing and eating
• hyperlipidaemia (abnormally high level of lipids in the blood).

Other medicines and Urizide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:

• aldesleukin (immunotherapy drug)
• general anaesthetic such as propofol and nitrous oxide
• antibacterials (used to treat bacterial infections) such as trimethoprim
• anti-depressants (used to treat depression) such as imipramine, amitriptyline, isocarboxazid and reboxetine
• anti-diabetics (used to treat diabetes) such as insulin
• anti-epileptics (used for epilepsy) such as carbamazepine
• anti-fungals (used to treat fungal infections) such as amphotericin
• anti-hypertensives (used for hypertension) such as enalapril, valsartan, nifedipine, diltiazem, atenolol and prazosin
• barbiturates (used for anxiety, depression and insomnia) such as phenobarbital
• calcium salts (such as calcium carbonate) and vitamins (such as vitamin D)
• calcium-channel blockers (such as amlodipine and verapamil) and peripheral vasodilators (such as moxisylyte)
• corticosteroids (used to reduce inflammation and suppress the immune system) such as cortisone, hydrocortisone and prednisolone
• diuretics (used to remove water from the body and are used to treat for high blood pressure and other conditions) such as acetazolamide, amiloride and furosemide
• dopaminergics (used in the treatment of Parkinson's di­sease, depression and anxiety) such as levodopa
• hormone antagonists (used to treat cancers e.g. toremifene and aminoglutethimide)
• nitrates (used to treat and prevent angina (heart pain, chest pain)) such as glyceryl trinitrate
• opioids (used to treat severe pain) such as morphine, tramadol and fentanyl
• prostaglandins (such as anti-inflammatory drugs e.g. aspirin and ibuprofen)
• theophylline (is used to treat lung diseases such as asthma, bronchitis and emphysema)
• sympathomimetics (used to treat cardiac arrest and low blood pressure) such as dopamine and epinephrine
• ulcer healing drugs such as amoxicillin and omeprazole
• anion exchange resins (used to treat hypercholeste­rolaemia a genetic condition with high cholesterol levels in the blood) such as colestipol and colestyramine
• analgesics (such as non-steroidal anti-inflammatory drugs (NSAIDs) e.g. indomethacin and ketorolac)
• oestrogens and progestogens (female hormones) such as the combined oral contraceptive pill
• anti-arrhythmics (used to treat an abnormality of the heart rhythm) such as amiodarone and lidocaine
• anti-histamines (used to treat allergies) such as loratadine and cetirizine
• anti-psychotics (used to treat bipolar disorder, schizophrenia and depression) such as pimozide
• anti-gout agents (used to treat gout) such as allopurinol
• ciclosporin (used as an immunosuppressant)
• cytotoxics (used to destroy cancer cells) such as cisplatin
• digoxin (used to treat congestive heart failure and heart rhythm problems)
• lithium (used to treat and prevent episodes of mania (frenzied, abnormally excited mood) in people with bipolar disorder)
• muscle relaxants (which helps relieve the pain and discomfort from muscle cramps) such as pancuronium and tizanidine.

Urizide with alcohol

Alcohol should be avoided. Drinking alcohol when taking this medicine may lead to dizziness on standing up.

Pregnancy, breast-feeding and fertility

Urizide should not be used in pregnant or breast-feeding women. Speak to your doctor or pharmacist before taking any medicine.

Driving and using machines

Urizide can cause dizziness, make sure you are not affected before driving or operating machinery.

Urizide contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Tests

During treatment with Urizide, your doctor may want to monitor your kidney function. If you are elderly or on long term treatment with Urizide, your doctor may want to monitor the level of chemicals in your body, by carrying out tests.

3. how to take urizidealways take this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure.swallow the tablets with water in the morning (to avoid frequent urination at night).

Recommended doses

Adults and children 12 years and over:

Oedema: initially 5–10 mg once a day or once every other day.

The maintenance dose is 5–10 mg one to three times a week.

High blood pressure: 2.5 mg once daily.

Children under 12 years: A more appropriate formulation may need to be used.

Initially 400 micrograms per kilogram of body weight, a day. The maintenance dose is 50–100 micrograms per kilogram of body weight, a day

Elderly: Your doctor may prescribe a lower dose, especially if you suffer from impaired kidney function.

If you take more Urizide than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.

Symptoms of an overdose can include feeling or being sick, diarrhoea, dehydration, dizziness, weakness, muscle cramps, increase in the frequency and amount of urination, thirst, low blood pressure, changes in the levels of salts and electrolytes in your blood and central nervous system depression (drowsiness, tiredness or coma). Treatment for overdosing involves fluid and electrolyte replacement.

If you forget to take Urizide

If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time. Do not take double dose to make for forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor at once if you experience the following:

• An allergic reaction (hypersensitivity) (frequency not known -frequency cannot be estimated from the available data): rashes including skin that is red, flaky and peeling (exfoliative dermatitis), sensitivity to sunlight or artificial light (e.g. sun beds), a viral infection of the lungs (pneumonitis) or fluid in the lungs (pulmonary oedema)
• Blood (frequency rare – may affect up to 1 in 1,000 people): altered numbers and types of blood cells. If you notice increased bruising, nosebleeds, sore throats, infections, collection of fluid in the lungs, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test
• blocked bile flow within the liver (which may present as jaundice – yellowing of the skin or whites of the eyes, dark urine and pale stools)
• decrease in vision or pain in your eyes (choroidal effusion) due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye or acute angleclosure glaucoma).
• Metabolism: Bendroflumethiazide may occasionally affect the level of sugar in the blood. If you are an insulin-dependent diabetic patient, you may need to have your dose of insulin adjusted as your body’s ability to deal with insulin may be affected if you are taking bendroflumethiazide at the same time; an increase in uric acid in your blood, causing gout; changes in blood lipid (fat) levels (shown in blood tests)
• Chemicals within the body (shown in blood tests): low blood potassium levels (hypokalaemia) (which may cause an increase in the frequency and amount of urination, a feeling of general discomfort and illness, muscle weakness or cramp, dizziness, feeling or being sick and loss of appetite), low blood magnesium and sodium levels, high levels of calcium in the blood (hypercalcaemia), low blood levels of chloride ions with increased alkalinity in the body (hypochloraemic alkalosis)
• Stomach and intestines: feeling or being sick, diarrhoea, constipation, stomach irritation, dry mouth and thirst
• Skin and subcutaneous tissue disorders: rashes, skin eruptions, Lichen planus (a rash that can affect different parts of your body, including inside your mouth), subacute cutaneous lupus erythematosus (SCLE) (a widespread non-scarring photosensitive

rash), erythema multiforme (skin reaction) and pseudoporphyria (a rare skin disease)

• Renal and urinary disorders: oliguria (the production of abnormally small amounts of urine), acute interstitial nephritis (AIN) (is a renal lesion that causes a decline in renal function) and kidney stones
• Investigations: increased triglyceride, total cholesterol, low density and very low density lipoprotein cholesterol concentrations, deficiency of potassium in the bloodstream, low magnesium concentration in blood, low sodium concentration in blood, high calcium concentration in blood, low chloride intake or excessive chloride wasting an excess of uric acid in the blood
• Other: inflammation of the pancreas, inability to maintain an erection, dizziness on standing due to low blood pressure (postural hypotension), dizziness.

5. how to store urizide

Keep this medicine out of the sight and reach of children.

Do not use the tablets after the expiry date, which is stated on the carton and blister packs. The expiry date refers to the last day of that month.

Do not store above 25°C. Keep the container tightly closed in order to protect from moisture. Store in the original container in order to protect from light.

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.

6. contents of the pack and other informationwhat urizide containsthe active substance is bendroflumethiazide. each tablet contains either 2.5 mg or 5 mg of bendroflumethiazide

The other ingredients are lactose, maize starch, pregelatinised starch, sodium starch glycollate and magnesium stearate.

What Urizide looks like and contents of the pack

Urizide 2.5 mg Tablets are white, round and plain tablets and approx. 5.5 mm in diameter.

Urizide 5 mg Tablets are white, round and plain tablets and approx. 6.5 mm in diameter.

Urizide is available in tablets in strengths of 2.5 mg and 5 mg, and in pack sizes of 28, 30, 50, 56, 60, 84, 100, 250,500 and 1000.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chelonia Healthcare Limited

11 Boumpoulinas, 3rd Floor Nicosia, P.C. 1060, Cyprus

Manufacturer

DDSA Pharmaceuticals Ltd., Chatfield Road, Off York Road, London SW11 3SE

Or

Meridian Healthcare (UK) Ltd., Rich Industrial Estate, Chatfield Road,

off York Road, Battersea,

London SW11 3SE

This leaflet was revised in April 2021.