Amiloride Tablets Bp 5mg
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AMILORIDE TABLETS BP 5mg Amiloride Hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
KEEP THIS LEAFLET AND READ IT BEFORE YOU TAKE YOUR MEDICINE
- 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 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 Amiloride tablets are and what they are used for
2. What you need to know before you take Amiloride tablets
3. How to take Amiloride tablets
4. Possible side effects
5. How to store Amiloride tablets
6. Contents of the pack and other information
1. What Amiloride tablets are and what they are used for
The name of your medicine is Amiloride Tablets BP 5mg. It contains Amiloride hydrochloride. It will be referred to as Amiloride tablets for ease hereafter.
Amiloride belongs to a group of medicines known as potassium sparing diuretics.
They act through increasing the flow of urine with reduction in the loss of potassium from the body and particularly in the following conditions:
i) Heart failure when patients are receiving thiazide diuretics.
ii) High blood pressure as an aid to other drugs used.
iii) Liver cirrhosis with fluid in the abdomen and swelling due to increased fluids in the legs and other areas under the skin.
2. What you need to know before you take Amiloride tablets
Do not take Amiloride Tablets if you:
• are allergic to Amiloride, or any of the other ingredients of Amiloride tablets (listed in section 6)
• have severe kidney disease including kidney disorder due to diabetes
• have difficulty passing urine • have too much potassium in the blood (hyperkalaemia) ) or you are taking other potassium conserving drugs or potassium supplements
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Amiloride tablets if you have:
• have lung disease
• have liver disease
• have kidney disorders such as impaired renal function
• have difficulty passing urine
• have diabetes (Diabetes mellitus)
• have or have had high levels of acid in the body (metabolic or respiratory acidosis)
• have galactose intolerance, Lapp lactase deficiency or glucose / galactose mal-absorption
• have cirrhosis (an abnormal liver condition in which there is irreversible scarring of the liver)
• are taking Amiloride Tablets with other diuretics (any medicine that promotes the production of urine)
Your doctor may monitor blood potassium levels, blood urea and serum electrolytes to establish the correct dosage for you.
Other medicines and Amiloride Tablets
Talk to your doctor if you are taking, have recently taken or might take any other medicines before using Amiloride Tablets.
ACE inhibitors (such as Captopril and Enalapril), Alpha-blockers (such as terazosin and doxazosin), or Angiotensin-II receptor antagonists and nitrates (to treat high blood pressure or heart failure)
• Medicines that affect blood pressure such as thiazide diuretics (bendroflumethiazide and hydrochlorothiazide), calcium channel blockers (Amlodipine), clonidine, diazoxide, hydralazine, minoxidil, moxonidine, nitroprusside
• Tacrolimus (to suppress the immune system)
• Pimozide (to control tics)
• Amisulpride, Sertindole (to treat mental disorders)
• Chlorpropamide (used to treat diabetes)
• Cyclosporin ( suppresses the immune system)
• Carbenoxolone (used to treat stomach ulcers)
• Potassium salts (for potassium depletion)
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ketorolac, indometacin, ibuprofen and diclofenac (used for pain relief)
• Medicines containing platinum (such as cisplatin and carboplatin) used to treat cancer
• Aldesleukin andTrilostane (used in certain cancers)
• Alprostadil and Moxisylyte (used for erectile dysfunction)
• General anaesthesia
• Medicines used to treat anxiety (such as anxiolytics)
• Medicines used to treat sleep disorders ( such as hypnotics)
• Baclofen and tizanidine (used as muscle relaxants)
• Lithium (used to treat depression)
• Other antidepressants such as MAOIs, tricyclics, St Johns Wort
• Methyldopa, (used in Parkinson’s disease)
• phenothiazines (including promethazine used to treat allergic reactions)
• Hormones such as corticosteroids, and oestrogens
It is important that your doctor is aware of any other medication you are taking. Your doctor will be able to identify medicines which you should not take with Amiloride Tablets.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. Amiloride Tablets should not be taken during pregnancy or breast-feeding; if in doubt contact your doctor.
Amiloride contains Lactose If you have been told you have an intolerance to some sugars, contact your doctor before taking Amiloride tablets, as it contains a type of sugar called lactose.
3. How to take Amiloride Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Take this medicine by mouth and only in the doses prescribed by your doctor. Do not take more of it, and do not take it more often or for a longer time than your doctor ordered. If you feel this medicine is not working as well as it should after you have taken it for a short time (1-2 weeks) do not increase the dose, instead check with your doctor. If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not double the dose.
Adults:
The initial dosage should be 2 tablets (10mg) either as a single dose or 1 tablet (5mg) twice a day. This may be increased if necessary, but must not exceed 20mg (4 tablets) per day. The dosage may subsequently be decreased by your doctor to the least amount he considers to be required (by 5mg reductions).
Congestive heart failure: Amiloride Tablets may be started at a dosage of 5mg (1 tablet a day), together with usual dosage of other diuretic medicines. If diuresis (passing of water) is not achieved with minimal dosage of both medicines, the dosage of both may be increased but that of Amiloride tablets should not exceed 10mg (2 tablets) per day. Once an adequate passage of urine has been achieved, reduction of dosage of both medicines may be attempted to maintain an adequate treatment.
Hypertension (high blood pressure):Amiloride Tablets are given at a dosage of 5mg or 10mg (1 or 2 tablets) a day, together with the usual anti-hypertensive dosage of other thiazide medicines.
Liver cirrhosis with fluid in the abdomen:
Treatment should be started with a small dose of Amiloride Tablets, i.e. 5mg (one tablet), plus a low dosage of the other diuretic agent. If necessary dosage of both agents may be increased gradually until there is effective passage of urine.
The dosage of Amiloride Tablets should not exceed 10mg (2 tablets) a day. Maintenance doses may be lower than those required to start the urinary flow; reduction in the daily dosage should therefore be attempted when the patient's weight has become stable. Gradual weight reduction in patients with cirrhosis is especially desirable to reduce the likelihood of untoward reactions. Elderly:
Because the elderly are more susceptible to adverse effects and because kidney function may be reduced, they are more likely to experience an increase in blood potassium which is undesirable. The dosage should be adjusted according to kidney function as determined by your doctor.
Use in Children:
The use of Amiloride Tablets is not recommended for children.
If you take more Amiloride tablets than you should
If you accidentally take more tablets than recommended contact your nearest doctor or hospital casualty department at once. Take any remaining tablets with you and keep in the original container or packaging so that they can be identified. If you feel this medicine is not working as well after you have taken it for a short time (1-2 weeks) do not increase the dose, instead check with your doctor.
If you forget to take Amiloride tablets
If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not take a double dose (two doses at once) to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of occurrence of these side effects is not known.
• Increased potassium level
• Thirst
• Nervousness
• Confusional state
• Unable to sleep
• Decreased sex desire
• Depression
• Sleepiness
• Dizziness
• Tingling, tickling, pricking of the skin
• Shakiness
• Abnormal brain function
• Headache
• Low blood pressure while sitting or standing
• Fluid pressure in the eye
• Ringing in the ears
• Chest pain
• Irregular heart beat
• Cough
• Hard to breathe, shortness of breath
• Nasal congestion
• Vomiting
• Diarrhoea
• Constipation
• Stomach ache
• Stomach bleeding
• Gas; upset stomach
• Dry mouth
• Itching
• Rash
• Hair loss
• Muscle spasm
• Back pain
• Joint pain
• Large passage of urine
• Painful urination
• Impotence
• Feeling of weakness
• Tiredness
• Anorexia (eating disorder characterized by an abnormally low body weight)
• Pain in the limbs
• Jaundice (a medical condition with yellowing of the skin or whites of the eyes)
• Bladder spasms
Most of the side effects of Amiloride Tablets are more likely to occur in the elderly as they are usually more sensitive to this medicine.
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 directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Amiloride tablets
Keep this medicine out of the sight and reach of children. Your medicine could harm them.
Store your medicine in a dry place, below 25°C. Protect from light. Keep the tablets in the container in which they were given to you.
Do not use this medicine after the expiry date shown on the label. The expiry date refers to the last day of that month.
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.
If your doctor tells you to stop the treatment, return any remaining tablets to the pharmacist, Only keep the medicine if the doctor tells you to.
6. Contents of the pack and other information
What Amiloride tablets contain
Each tablet contains 5 mg of the active ingredient, Amiloride Hydrochloride, together with the inactive ingredients lactose, calcium hydrogen phosphate, pregelatinised maize starch, maize starch, magnesium stearate and purified water.
What Amiloride tablet looks like and contents of the pack
Amiloride Tablets are available in containers of 100 and 500 tablets, and in blister packs of 28, and 84 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd.
Capital House,
1st Floor,
85 King William Street,
London EC4N 7BL
Manufacturer
For any information about this medicine, please
contact the Marketing Authorisation Holder. Leaflet was last revised on January 2015