Patient leaflet - Co-amilozide tablets 5/50 mg
1. WHAT CO-AMILOZIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Co-amilozide tablets contain the active ingredients amiloride hydrochloride and hydrochlorothiazide. Both of these actives belong to a group of medicines called diuretics (water tablets).
Co-amilozide tablets are used in the treatment of high blood pressure and to treat heart failure. Co-amilozide tablets are also used to treat other conditions where fluid retention occurs, including a liver disease called hepatic cirrhosis.
Co-amilozide tablets can also be used in patients where loss of potassium in the blood is anticipated or suspected.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-AMILOZIDE TABLETS
Do not take Co-amilozide tablets if:
! you are allergic to amiloride hydrochloride, hydrochlorothiazide or
any of the other ingredients in these tablets (listed in section 6) ! you are allergic to medicines called sulphonomides (for the
treatment of infections)
! you have been told you have a high level of potassium, calcium,
urea or creatinine in your blood
! you are taking other potassium containing products including
supplements and potassium rich foods
! you are currently taking potassium sparing diuretics such as
spironolactone and triamterene (see section Other medicines and Co-amilozide tablets)
! you are not passing water (urine)
! you have severe kidney disease
! you have severe liver failure
! you have Addison's disease
! you are taking lithium (used to treat manic depression) ! you have diabetes or diabetic neuropathy (diabetic nerve damage
causing pain, weakness or numbness).
Co-amilozide tablets should not be used in children under 18 years of age
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Co-amilozide tablets if you have:
! liver cirrhosis with swelling of the abdomen (ascites) and
abnormally high levels of alkalinity in the body (metabolic alkalosis)
! had high levels of acid in the body (metabolic or respiratory
acidosis) caused by heart disease or poorly controlled diabetes ! water retention causing swelling (resistant oedema) ! taken digitalis such as digoxin which is used to treat heart failure
and abnormal heart beat
! gout (a condition where too much uric acid in the body causes
joint pains)
! been told you are due to take a glucose tolerance test (this
medicine should be discontinued at least 3 days before) ! been told by your doctor you have high levels of uric acid,
cholesterol or triglycerides (a type of cholesterol) in your blood ! severe asthma
! recently suffered from severe vomiting or diarrhoea ! a serious illness or are elderly
! severe liver disease
! impaired kidney function
! had surgery affecting nerves
! had systemic lupus erythematosus (SLE) a disease where the
immune system attacks the tissues of the body
! had skin cancer or if you develop an unexpected skin lesion
during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Co-amilozide tablets.
! 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 Co-amilozide tablets. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy you can be at higher risk of developing this.
Co-amilozide tablets contain lactose and sunset yellow (E110)
If you have been told by your doctor that you have an intolerance to some sugars, you should talk to your doctor before taking these tablets.
These tablets contain E110 (sunset yellow) which may cause allergic reactions.
3. HOW TO TAKE CO-AMILOZIDE TABLETS
Always 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 a drink of water.
The recommended dose is:
Treatment of high blood pressure
One tablet taken once a day. Your doctor may decide to increase your dose up to two tablets a day.
Treatment of heart failure
One tablet taken once a day. Your doctor may decide to increase your dose up to four tablets a day.
Treatment of liver cirrhosis
Two tablets taken once a day. Your doctor may decide to increase your dose up to four tablets a day.
Your doctor may change the dose depending upon your response to these tablets. Exactly how much you should take will be on the dispensing label of the packet.
Elderly
The dosage will depend on your kidney function, blood chemical levels and response to treatment.
Use in children
This medicine is not recommended in children under 18 years of age.
If you take more Co-amilozide tablets than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause dehydration and an imbalance of blood mineral salt in the body (causing abnormal heart rhythm, muscle twitching, muscle weakness, tiredness and confusion). Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Co-amilozide tablets
If you forget to take your tablet, take the missed dose as soon as you remember unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. Then continue to take your tablets at the correct times. If you have trouble remembering when to take your tablets talk to your doctor.
If you stop taking Co-amilozide tablets
You should finish all the tablets your doctor has prescribed. Even if you feel better you should not stop taking these tablets before talking to your doctor.
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.
If you experience any of the following, stop taking Co-amilozide tablets and see a doctor immediately:
Serious side effects
Difficulty swallowing, redness, blisters, peeling skin, muscle pain, chills, generally feeling unwell (malaise), ulcers in your mouth, eyes or genitals, or inflammation of blood vessels (necrotising angiitis).
Severe allergic reactions (anaphylactic reaction) - signs can include feeling lightheaded or faint, breathing difficulties, wheezing, a fast heartbeat, sweating, confusion, anxiety, collapse, losing consciousness, pale or red irregular raised rash with severe itching (hives), feeling or being sick, swelling (angioedema), or stomach pain.
Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
Other reported side effects:
! Blood: altered numbers and types of blood cells causing
increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin (you may need a blood test), or blood spots, bruising and discolouration of the skin (purpura).
! Heart: chest pain (angina) or irregular, fast or pounding heartbeat
(arryhthmia, tachycardia or palpitation).
! Senses: feeling of dizziness or spinning (vertigo), or ringing in the
ears (tinnitus), increased pressure in the eye (increased intra-ocular pressure) or visual disturbances and yellow vision (xanthopsia).
! Stomach and gut: feeling of stomach fullness, stomach irritation,
activation of stomach ulcers, constipation, diarrhoea, inflammation of salivary glands, indigestion, wind, dry mouth, stomach or intestinal bleeding or pancreatitis.
! Liver: changes in liver function or jaundice (yellow skin or eyes).
! Infections: sialadentitis (an infection of the salivary glands).
! Metabolism: anorexia, changes in appetite, dehydration, gout, changes in levels of body chemicals (increased blood potassium, glucose or uric acid or decreased blood sodium).
! Muscles and joints: back, neck and shoulder aches and pains, joint pain, pain in the hand or feet or muscle cramps.
! Nervous system: dizziness, sleepiness, near unconsciousness including reduced mental activity and reduced response to simulation (stupor), pins and needles (paraesthesia), tremors, a change in taste (dysgeusia) or encephalopathy (memory loss is a common symptom).
! Mental disorders: decreased libido, depression, sleeping difficulties (insomnia), nervousness and restlessness.
! Kidney and urinary: incontinence, pain on passing water, bladder pain, glucose in the urine, kidney inflammation or failure, impaired kidney function, getting up in the night to pass water, frequent or copious water production or urinary infrequency.
! Genital: inability to maintain an erection (impotence).
! Lungs and airway: cough, fluid in the lungs and lung inflammation (pneumonitis), hiccups or nasal congestion.
! Skin: hair loss (alopecia), sensitivity to light (photosensitivity), skin rash, itching or pemphigoid (condition presenting with fluid-like blisters on the skin).
Frequency not known (cannot be estimated from the available data): Skin and lip cancer (Non-melanoma skin cancer).
! Circulatory system: dizziness on standing due to low blood pressure or flushing.
! Other: chest pain, feeling tired (fatigue), fever, headache, weakness, thirst or digitalis toxicity (fatigue, malaise and visual disturbances).
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 at: 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 CO-AMILOZIDE TABLETS
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or label. The expiry date refers to the last day of that month.
Store below 25°C. Protect from moisture and 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 INFORMATION
What Co-amilozide tablets contain
Co-amilozide tablets contain 5mg of amiloride hydrochloride and 50mg of hydrochlorothiazide.
The other ingredients are lactose, microcrystalline cellulose, maize starch, magnesium stearate, purified talc, sodium starch glycollate and sunset yellow (E110).
What Co-amilozide tablets look like and contents of the pack
Co-amilozide tablets are flat, pale peach bevelled edged tablets bisected on one side, embossed 'C4' on the other.
Co-amilozide tablets are available in packs of 28, 50, 100 and 500 tablets
Marketing Authorisation Holder
Ennogen IP Ltd
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Manufacturer
Ennogen Healthcare International Ltd
Unit G3, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.