Amiloride 5mg – patient leaflet, side effects, dosage

1. What Amiloride 5mg tablets are and what are they used for

Amiloride 5mg tablets belong to a group of medicines called diuretics (water tablets). Amiloride 5mg tablets can be used on their own (monotherapy) or with other drugs such as thiazide diuretics. They may be used for:

• high blood pressure
• congestive heart failure
• liver cirrhosis with swelling of the abdomen (ascites).

2. What you need to know before you take Amiloride 5mg tablets

Do not take Amiloride 5mg tablets if you:

• are allergic to amiloride hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• are giving the tablets to a child
• are taking any potassium conserving drugs or potassium supplements
• are not producing any urine
• are pregnant or breastfeeding
• have high blood levels of potassium (hyperkalaemia)
• have severe kidney disease or kidney failure
• have diabetic neuropathy (diabetic nerve damage causing pain, weakness or numbness).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking Amiloride 5mg tablets.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Amiloride 5mg tablets if you:

• have or have had high levels of acid in the body (metabolic or respiratory acidosis) caused by heart disease
• have severe liver disease
• have kidney impairment
• have disturbances of blood chemicals
• are elderly.
• have diabetes

Children

Amiloride 5mg tablets are not to be used in children

Other medicines and Amiloride 5mg tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Especially:

• lithium (for some mental illnesses)
• antidiabetic drugs such as chlorpropamide
• ciclosporin and tacrolimus (used in rheumatism, psoriasis and to prevent organ rejection)
• medicines for high blood pressure such as ACE inhibitors (captopril or enalapril), Angiotensin II antagonists (losartan, valsartan), beta blockers (sotalol), calcium channel blockers (amlodipine, diltiazem), adrenergic neurone blockers, alpha-blockers (prazosin), clonidine, diazoxide, methyldopa, moxonidine, hydralazine, minoxidil and sodium nitroprusside
• non-steroidal anti-inflammatory drugs (NSAIDs) for pain e.g. ibuprofen or naproxen
• antidepressants such as MAOIs, tricyclics, St John's Wort
• carbamazepine (used in epilepsy)
• aldesleukin and trilostane (used in certain cancers)
• general anaesthetic
• antipsychotics such as amisulpride and pimozide, phenothiazines such as chlorpromazine or anxiolytics and hypnotics such as diazepam (used in mental illness)
• atomoxetine (used to treat ADHD)
• corticosteroids used to reduce inflammation
• levodopa (used in Parkinson’s disease)
• moxisylyte (used in Raynaud’s syndrome)
• muscle relaxants such as baclofen and tizanidine
• nitrates (used for certain heart conditions)
• oestrogen and drospirenone (contraception (female hormones))
• alprostadil (used for erectile dysfunction)
• potassium salts

• prostaglandin synthetase inhibitors (used for pain, fever and inflammation).

  Amiloride 5mg tablets with alcohol

  Avoid alcohol when taking this medicine, as your blood pressure may drop too much.

  Pregnancy, breast-feeding and fertility

  The use of Amiloride 5mg tablets is not recommended in pregnant women. Contact your doctor before breast feeding as you should either not breast feed or stop taking Amiloride 5mg tablets.

  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.

  Driving and using machines

  If you feel dizzy while taking Amiloride 5mg Tablets, do not drive or operate dangerous machinery.

  Diabetic tests

  If you are to be tested for diabetes or need to have other tests related to diabetes, tell your doctor you are taking Amiloride 5mg tablets. The tablets may need to be stopped at least three days before the test, as they can interfere with the results

  Amiloride 5mg tablets contain lactose

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

  Information on sodium content

  This medicine contains less than 1 mmol (23mg) sodium per tablet, that is to say essentially ‘sodium-free’.

3. How to take Amiloride 5mg tablets

Always take Amiloride 5mg tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Swallow the tablets.

The recommended dose is:

Monotherapy:

Two tablets a day either as a single or divided dose, to a maximum of four tablets a day and then gradually reduced to a maintenance dose.

High blood pressure:

One to two tablets a day up to four tablets a day.

Congestive heart failure:

One to two tablets a day up to four tablets a day and then gradually reduced to a maintenance dose.

Liver cirrhosis with swelling of the abdomen (ascites):

One tablet initially up to four tablets and then gradually reduced to a maintenance dose.

Elderly:

The dosage will depend on your kidney function, blood chemical levels and response to treatment. If you are elderly, it is particularly important to take this medicine exactly as prescribed.

Children:

Not recommended.

If you take more Amiloride 5mg tablets 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 include dehydration and changes in the levels of certain chemicals in the blood.

If you forget to take Amiloride 5mg tablets

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 a double dose to make up for a 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.

The frequencies of the side effects listed below are classified as follows:

Very common: in more than 1 in 10 patients Common: in 1 to 10 in 100 patients Uncommon: in 1 to 10 in 1,000 patients Rare: in 1 to 10 in 10,000 patients

Very rare: in fewer than 1 in 10,000 patients Not known: cannot be determined from the available data.

Stop taking this medicine and go to your nearest Accident and Emergency department or contact your doctor immediately if you get any of the following signs of an allergic reaction:

• swelling of the face, lips, tongue or throat, difficulty in swallowing or breathing or a skin rash

Please tell your doctor or pharmacist if you notice any of the following side effects, they get worse or if you notice anything not listed.

Blood and lymphatic system disorders Not known: Anaemia, blood disorder (lack of white blood cells) associated with increased susceptibility to infections (neutropenia).

(675936) Date: 01-06-17, (R) 13.09.2024, 16.09.2024 Nervous system disorders

Not known: Tremors, brain disorder characterised by, for example, convulsions and reduced consciousness (encephalopathy).

Eye disorders

Not known: Increased eye pressure.

Ears and labyrinth disorders

Not known: Tinnitus.

Cardiac disorders

Not known: Palpitations. A patient with a partial heart block developed a complete heart block.

Respiratory, thoracic and mediastinal disorders Not known: Coughing.

Gastrointestinal disorders

Not known: Activation of an already existing stomach ulcer; disturbed digestion with symptoms of a full feeling in the upper abdomen, pain in the stomach area, belching, nausea, vomiting and heartburn (dyspepsia); dry mouth.

Hepatobiliary disorders

Not known: Abnormalities in liver function, jaundice.

Skin and subcutaneous tissue disorders Not known: Hair loss.

Renal and urinary tract disorders

Not known: Urinating more, having to urinate small amounts more often (pollakiuria), cramps in the bladder.

Reproductive system and breast disorders Not known: Less desire for sex.

General disorders

Not known: Pain in neck and shoulder, pain in limbs.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Amiloride 5mg tablets

Container packs: Do not store above 25°C. Keep in the original container. Keep the container tightly closed.

Blister packs: Do not store above 25°C. Store in the original package in order to protect from light.

Keep out of the sight and reach of children.

Do not take this medicine after the expiry date stated on the carton or label. 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. These measures will help to protect the environment.

6. Contents of the pack and other information

What Amiloride 5mg Tablets contain

The active substance is Amiloride

hydrochloride.

The other ingredients are Lactose

monohydrate, Dibasic calcium phosphate dihydrate, Pregelatinised starch, Maize starch, Sodium starch glycolate and Magnesium stearate (see section 2 for Important information about some of the ingredients of Amiloride 5mg tablets).

What Amiloride 5mg tablets looks like and contents of the pack

Amiloride 5mg tablets are off white to creamy white, round, flat, uncoated, debossed with C and G on either side of the breakline and plain on the other side.

They are available in container packs of 100 and 500 tablets. They are also available in the blister packs of 28 and 84 tablets (Not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

This leaflet was last revised in September 2024.

(675936) Date: 01-06-17, (R) 13.09.2024, 16.09.2024

10 0013 1 675936 INP001