Patient leaflet - Amiloride Hydrochloride 5 mg tablets
1. What Amiloride Hydrochloride Tablets are and what they are used for
The name of this medicine is Amiloride Hydrochloride 5 mg Tablets. The active ingredient is amiloride hydrochloride. This belongs to a group of medicines called diuretics (water tablets).
Amiloride can be used to stop the build up of extra water in your body. It does this without loss of potassium from your body. This extra water can lead to high blood pressure, heart problems (congestive heart failure) and liver problems (hepatic cirrhosis).
It works by helping you to pass more water (urine) than you usually do.
2. What you need to know before you take Amiloride Hydrochloride Tablets
Do not take Amiloride Hydrochloride Tablets if:
You are allergic (hypersensitive) to amiloride
hydrochloride or any of the other ingredients of this medicine (listed in section 6 of this leaflet). Signs of an allergic reaction include: a rash, itching or shortness of breath.
- You have kidney problems.
Your doctor has told you that you have high potassium
levels, or you are taking other potassium conserving drugs or potassium supplements.
The person taking the medicine is a child under 18 years
old.
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 Hydrochloride Tablets.
Warnings and Precautions
Before you take Amiloride Hydrochloride Tablets tell your doctor if:
- You are elderly or seriously ill
- You have diabetes
- You have liver problems
Your doctor has told you that you have too much acid in
your blood. This can be caused by diabetes or heart or lung disease.
If you are not sure if any of the above applies to you, talk to you doctor or pharmacist before taking Amiloride Hydrochloride Tablets
Tests
Tell your doctor or nurse you are taking Amiloride Hydrochloride Tablets if you are going to have a glucose tolerance test. This is because this medicine can affect the results. You will need to stop taking this medicine three days before your test.
Children and adolescents
Do not give this medicine to children and adolescents under the age of 18 because the safety and effect of Amiloride Hydrochloride Tablets in this age group has not been established.
PATIENT INFORMATION LEAFLET
AMILORIDE HYDROCHLORIDE 5 MG TABLETS
(Amiloride Hydrochloride)
Other medicines and Amiloride Hydrochloride Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking some medicines together can be harmful.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Lithium – used for depression
Medicines used to treat high blood pressure including
ACE inhibitors, angiotensin-II antagonists, alpha-blockers, beta-blockers, calcium channel blockers and hydralazine
- Nitrates – used for angina
- Quinidine – used to treat heart rhythm disorders
Medicines or supplements containing potassium
(including table salt substitutes)
- Trilostane – used for ‘Cushings syndrome’ or breast cancer
Aldesleukin – used to treat kidney and skin cancer
(melanoma)
- Ciclosporin or tacrolimus – used after transplants to stop the rejection of organs
- General anaesthetics, used to stop pain during surgery
- Non-steroidal anti-inflammatory (NSAID) medicines such as indomethacin, diclofenac and ibuprofen. Your doctor may want to carry out tests on your kidneys and the level of potassium in your blood, especially if you are an older person
- Chlorpropamide – used to treat diabetes
- Carbamazepine – used for epilepsy
- Levodopa – used to treat Parkinson’s disease
- Medicines used to treat depression including tricyclic antidepressants (such as amitriptyline) and monoamine oxidase inhibitors (MAOIs – such as phenelzine)
- Phenothiazines – used to treat mental illness
- Medicines used to treat inflammation (such as cortisone and hydrocortisone)
- Tizanidine or baclofen – used to relax muscles
- Carbenoxolone – used to treat stomach ulcers
- Some oral contraceptives (the pill) or oestrogen (female sex hormone) preparations
- Alprostadil – used to treat male impotence and for heart defects in infants.
This medicine does not cause loss of potassium from your body as other water tablets do. Therefore, it is not necessary for you to get extra potassium in your diet or take supplements. Too much potassium could be harmful.
If you are unsure of the types of medicines you are taking, ask your doctor or pharmacist.
Taking Amiloiride Hydrochloride Tablets with food and drink
If you feel dizzy while taking the tablets, drinking alcohol can make this problem worse.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, planning to become pregnant or are breast-feeding.
Driving and using machines
If you feel dizzy while taking Amiloride Hydrochloride Tablets, do not drive or operate dangerous machinery.
Amiloride Hydrochloride Tablets contain lactose monohydrate and wheat starch
This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.
This product contains only very low levels of gluten (from wheat starch). It is regarded as gluten free and is very unlikely to cause problems if you have coeliac disease.
One tablet contains no more than 0.836 micrograms of gluten. If you have wheat allergy (different from coeliac disease) you should not take this medicine.
3. How to take Amiloride Hydrochloride Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. You should check with them if you are not sure.
The score-line is not intended for breaking the tablets.
How much should you take?
Adults - The usual dose for adults is:
Amiloride Hydrochloride Tablets taken alone
- 10 mg each day
- This may be increased to 20 mg each day
Amiloride Hydrochloride Tablets taken with other diuretics, high blood pressure and congestive heart failure
- 5 mg or 10 mg each day
Cirrhosis of the liver
- 5 mg each day
Children
This medicine is not usually given to children under the age of 18.
Older People
Your doctor will decide how many Amiloride Hydrochloride Tablets to give you.
How to take this medicine:
- Take this medicine by mouth
- If you are taking a single dose, take it in the morning
If you are taking more than one dose, take the last dose
before 6 pm, unless your doctor tells you otherwise
Plan your doses so that they do not affect your personal
activities and sleep
Your doctor will check your progress regularly to make
sure the medicine is working properly.
If you take more Amiloride Hydrochloride Tablets than you should:
If you accidentally take too many tablets, or someone else takes any of your medicine, you should tell your doctor at once or contact the nearest accident and emergency department. Show any left-over medicines or the empty packet to the doctor.
If you forget to take Amiloride Hydrochloride Tablets:
Do not take a double dose (two doses at the same time) to make up for a forgotten dose. Take your next dose as soon as you remember, then go on as before. However, if it is nearly time for the next dose, skip the missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Amiloride Hydrochloride Tablets can cause side effects, although not everybody gets them.
If you have an allergic reaction to Amiloride Hydrochloride Tablets, see a doctor straight away
An allergic reaction may include:
Any kind of skin rash, flaking skin, boils or sore lips and
mouth
Sudden wheezing, fluttering or tightness of the chest or
collapse
If you get any of the following side effects, stop taking Amiloride Hydrochloride Tablets and see your doctor as soon as possible:
- Chest pain including angina pain
- Unusual heart beats
- Yellowing of the skin and the whites of the eye (jaundice)
- Feeling dizzy, particularly when standing up
- Disease of the brain (encephalopathy)
- Difficulty in breathing
- Problems with your sight
Changes in the results of blood tests. These include
changes in the way your liver is working or changes in red or white blood cell levels. They also include changes in sodium or potassium levels which can cause dry mouth, thirst, headache, muscle cramps or weakness
Tell you doctor if you get any of these side effects:
- Feeling sick or being sick
- Diarrhoea or constipation
- Stomach pain
- Skin rash, itching
- Hair loss
- Pins and needles
- Feeling confused
- Mood or personality changes
- Feeling sleepy
- Coughing
- Changes in your sexual drive or function
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 at http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in 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 Hydrochloride Tablets
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any specific storage conditions.
Do not use Amiloride Hydrochloride Tablets after the expiry date on the carton and blister as [EXP XX/YYYY]. 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.
6. Contents of the pack and other information
What Amiloride Hydrochloride Tablets contain:
Each tablet contains 5 mg of amiloride hydrochloride as the active ingredient.
The tablets also contain lactose monohydrate, wheat starch, povidone, sodium starch glycolate (Type A), magnesium stearate and quinoline yellow (E104).
What Amiloride Hydrochloride Tablets look like and contents of the pack:
The tablets are yellow, round shaped, biconvex tablets with a score-line on one side.
Amiloride Hydrochloride Tablets are available in blister packs of 20, 28, 30 and 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Somex Pharma
Ilford, Essex
IG3 8BS. UK
Manufacturer:
Kleva Pharmaceuticals S.A.
189 Parnithos Avenue
136 75 Acharnai
Athens
Greece
This leaflet was last revised in February 2023.
Other sources of information:
To request a copy of this leaflet in braille or large print, please call 020 8590 9399 (UK Only).