Co-amilozide tablets BP 5/50 mg – patient leaflet, side effects, dosage

1. WHAT CO-AMILOZIDE TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Co-Amilozide Tablets 5/50mg. They contain the active ingredient Amiloride Hydrochloride and Hydrochlo-rothiazide. Amiloride Hydrochloride is a potassium sparing diuretic. Amiloride is a weaker diuretic that causes potassium to be retained in the body. It is used in combination with the hydrochlorothiazide in this medicine to prevent the amount of potassium in the blood from falling too low. Hydrochlorothiazide is a thiazide diuretic. These work by increasing the volume of urine you produce, therefore reducing the water content of your blood and in turn the volume of blood circulat-ing in your body. Hydrochlorothiazide can cause potassium to be filtered out of the blood, which can sometimes cause the level of potassium in the blood to fall too low. The two are commonly prescribed together to get rid of excess water from the body without also losing potassium.

Co-amilozide Tablets may be used for:

• high blood pressure (hypertension)
• congestive heart failure.
• Hepatic cirrhosis with ascites (chronic disease of the liver characterized by the replacement of normal tissue with fibrous tissue and the loss of functional liver cells), where there is a build-up of excess water in the body (fluid retention).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-AMILOZIDE TABLETS

Do not take Co-amilozide if:

• You are allergic to Amiloride, Hydrochlorothiazide, other Sulfonamide-derived medicines or any of the other ingredients of this medicine (See Section 6 “Contents of the pack and other information”)
• If you have high levels of potassium in the blood [hyperkalaemia] (especially if you are elderly, diabetic or suffer from liver or heart failure), are currently taking potassium-sparing diuretics such as spironolactone or triamterene (see “Other medicines and Co-amilozide”), potassium supplements or potassium-rich foods (unless you have severely low levels of potassium and you are being carefully monitored)
• You suffer from kidney failure, kidney disease or other kidney problems such as anuria (failure of the kidneys to produce urine)
• You suffer from sever liver failure or severe liver disease (hepatic cirrhosis)
• You suffer from Addison’s disease
• You have high levels of calcium in the blood (hypercalcaemia). Treatment with Co-amilozide should be discontinued before carrying out tests for parathyroid function
• You are taking lithium (see “Other medicines and Co-amilozide”)
• You suffer from diabetes (see “Warnings and precautions” section) or diabetic neuropathy (kidney disease or damage that can occur in people with diabetes)
• You have high levels of urea or creatinine in the blood (may be a sign of kidney problems)

Warnings and precautions

Talk to your doctor before taking Co-amilozide:

• If you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Co-amilozide, seek medical attention immediately
• If you experience 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. 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.
• If you have high levels of potassium in the blood [hyperkalaemia] (especially if you are elderly, diabetic or suffer from liver, heart or kidney failure)
• If you are currently taking potassium supplements or potassium-rich foods (unless you have severely low levels of potassium and you are being carefully monitored)
• If you suffer from kidney problems, including abnormally high levels of blood urea nitrogen (uraemia)

• If you show signs of fluid and electrolyte imbalance [symptoms include dry mouth, weakness, lack of energy, drowsiness, restlessness, fits, confusion, muscle pain, cramps, low blood pressure (hypotension), decreased production of urine (oliguria), faster heartbeat (tachycardia), feeling sick (nausea) or being sick (vomiting), particularly if you are elderly or receiving long-term treatment]:

  • Low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma (hyponatraemia), particularly if you are elderly or suffering from severe heart failure
  • Abnormally high alkalinity of the blood and body fluids (hypochloraemic alkalosis)
  • Abnormally low levels of potassium in the blood (hypokalaemia)
  • An abnormally low level of magnesium in the blood (hypomagnesaemia)
• If you suffer from liver problems or liver disease
• If you have an abnormally high level of uric acid in the blood (hyperuricaemia)
• If you suffer from gout (pain and swelling in one or more joints)
• If you are diabetic. The status of kidney function should be determined before Co-amilozide is given to known or suspected diabetics. Co-amilozide should be discontinued for at least 3 days before giving a glucose-tolerance test as HCT may impair the results. Diabetes may be caused or aggravated by treatment with Co-amilozide. Dosage adjustment of anti-diabetic medicines, including insulin, may be required (see “Other medicines and Coamilozide”)
• If you have increased level of fats (cholesterol and triglyceride) in your blood
• If you suffer from or have previously suffered from increased acidity in the blood (acidosis)

• If you suffer from Systemic Lupus Erythematosus (long-term inflammation of skin)

  • If you have 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.

Other medicines and Co-Amilozide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines. Medicines which may interact with or be affected by Co-amilozide:

• Aldesleukin, a medicine used to treat cancer of the kidney
• Medicines used to increase frequency of urination e.g. spironolactone, triamterene, bendroflumethiazide, acetazolamide (diuretics)
• Medicines used to treat Parkinson’s disease e.g. amantadine, levodopa
• Hormonal medicines e.g. toremifene, oestrogens
• Potassium supplements, calcium and vitamin D
• Medicines used to treat heart failure e.g. digoxin (cardiac glycosides)
• Lithium, a medicine used to treat mood disorders (anti-psychotic)
• Medicines used to treat diabetes e.g. insulin, chlorpropamide (anti-diabetics)
• Diazoxide, a medicine used to treat a low blood sugar level
• Halofantrine, a medicine used to treat malaria
• Medicines to treat mental illness e.g. primozide and sertindole
• Carbamazepine, a medicine used to treat epilepsy
• Amphotericin and fluconazole, medicines used to treat fungal infections
• Allopurinol, a medicine used to prevent gout
• Medicines used to treat allergies e.g. astemizole and terfenadine (anti-histamines)
• Medicines used to treat certain rheumatic disorders such as aspirin or ibuprofen (Non-Steroidal Anti-Inflammatory Drugs - NSAIDs)
• Medicines used to reduce the body’s immunity when receiving organ transplant e.g. ciclosporin, tacrolimus (immunosuppressants)
• Medicines used to treat Cushing’s syndrome e.g. trilostane
• Medicines used to treat high blood pressure such as methyldopa, enalapril (ACE [Angiotensin-Converting Enzyme] inhibitors). Co-amilozide should be discontinued for 2-3 days before starting treatment with an ACE inhibitor
• Other medicines used to treat high blood pressure such as losartan (angiotensin II receptor antagonists), prazosin (alpha blockers), hydralazine (beta blockers), verapamil (calcium channel blockers)

• Medicines used to lower cholesterol e.g. cholestyramine, colestipol

  • these should be given at least 2 hours apart
• Medicines used to reduce inflammation such as cortisone, hydrocortisone (corticosteroids)
• Corticotropin (AdrenoCorticoTropic Hormone - ACTH)
• Medicines used to treat serious allergic reaction (anaphylaxis) such as epinephrine (adrenaline) and noradrenaline (sympathomimetics)
• Carbenoxolone, a medicine used to treat stomach ulcers
• Tubocurarine, tizanidine, muscle relaxants
• Nitrates, to treat angina
• Alprostadil, a medicine used to treat erectile dysfunction (vasodilator)
• Barbiturates, medicines used in sedation and anaesthesia
• Quinidine, a medicine used to treat abnormal heart rhythms (anti-arrhythmic)
• Trimethoprim, a medicine used to treat bacterial infections
• Medicines to treat depression e.g. reboxetine, tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs)
• Analgesic medicines used to relieve pain
• Treatment with Co-amilozide should be stopped before having a parathyroid function test or kidney function test as it may affect the results

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Effects on laboratory tests

If you need to have any tests such as blood tests, urine tests, liver function, adrenal function or diabetes tests, tell the doctor that you are taking Co-Amilozide Tablets. You may need to stop taking the tablets before you take these tests.

Taking Co-Amilozide Tablets with food or alcohol

During treatment with Co−amilozide, it is advisable not to drink alcohol as this may cause you to become dizzy or faint on standing up from a resting position . Do not eat foods which have a high potassium content (such as bananas). It is important to follow any dietary advice that you have been given by your doctor. If you are overweight, your doctor may want you to follow a weight reducing diet.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you are pregnant or if you think that you are. Usually, your doctor will advise you to take another medicine instead of Co-amilozide, as Co-amilozide is not recommended during pregnancy. This is because Co-amilozide crosses the placenta and its use after the third

month of pregnancy may cause potentially harmful foetal and neonatal effects.

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Co-amilozide is not recommended for mothers who are breast-feeding

Driving and using machines

You may have a headache or problems with your vision, or you may feel weak, tired, dizzy, dazed or experience a feeling of “spinning” (vertigo), whilst taking this medicine.

If any of these symptoms are experienced, it may be necessary to avoid driving or operating machinery or pursuing any activity in which full attention is required If you have diabetes, Co-Amilozide Tablets

may affect your blood sugar levels. Test your urine or blood regularly and report any extreme changes to your doctor.

Co-Amilozide contains lactose, sodium and sunset yellow E110

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

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Also contains sunset yellow E110 which may cause allergic reactions.

3. HOW TO TAKE CO-AMILOZIDE TABLETS

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will have decided how many Co-Amilozide Tablets you need to take each day depending on your condition.

Swallow your tablets with a glass of water.

• These tablets are to be taken orally as a single dose in the morning.
• These tablets should be taken independently of meals and with a generous amount of fluid.
• The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

The rate of loss of weight and the serum electrolyte levels should determine the dosage. The most satisfactory rate of weight loss after initiation of diuresis is about 0.5 to 1.0 kg per day.

Adults: Hypertension (high blood pressure):

Initially, a single daily dose of Co-amilozide 2.5/25mg. This tablet can only be used to provide a 5/50 mg dose. The tablet should not be split to provide a 2.5/25 mg dose. A different Co-amilozide 2.5/25 mg tablet should be used.

If necessary, the dose may be increased to Co-amilozide 5/50 mg taken as a single daily dose or in divided doses. Co-amilozide may be used alone or with other medicines used to treat high blood pressure, but the dosage of the other medicines may need to be lowered to reduce the risk of an excessive drop in blood pressure.

Congestive heart failure (Heart problems which can cause shortness of breath or ankle swelling):

Initially, a single daily dose of Co-amilozide 2.5/25 mg. This tablet can only be used to provide a 5/50 mg dose. The tablet should not be split to provide a 2.5/25 mg dose. A different Co-amilozide 2.5/25 mg tablet should be used. This may be adjusted if required but should not exceed two Co-amilozide 5/50mg tablets a day. A reduction in dose may be attempted for maintenance treatment.

To treat liver disease with an excessive accumulation of fluid: Treatment should be started with a low dose. A single daily dose of one Co-amilozide 5/50 mg tablets may be increased gradually, but dosage should not exceed two Co-amilozide 5/50 mg tablets a day. Maintenance doses may be lower than those required initially. Dose reduction should be attempted once the patient’s weight is stabilised.

Elderly: The dose may need to be adjusted depending on how well your kidneys work and how well you respond to treatment with this medicine.

Children: Not recommended for use in children under 18 years of age.

If you take more Co-Amilozide Tablets than you should

If you take more Co-Amilozide Tablets than you should, contact your doctor or nearest hospital emergency department immediately. Take the pack and remaining tablets with you.

The symptoms of overdose include: coma, breathing difficulties. The most common symptoms of overdose are dehydration and electrolyte imbalance:

• abnormally low levels of potassium in the blood (hypokalaemia)
• abnormally low level of the chloride ion in the blood (hypochloraemia)
• low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma (hyponatraemia)

If you forget to take Co-Amilozide Tablets

If you forget to take a dose, take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Co-Amilozide Tablets

Do not stop taking Co-Amilozide Tablets without talking to your doctor, even if you feel better. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. It is important that you keep taking Co-amilozide for as long as your doctor has told you to. Do not stop or change your treatment before talking to your doctor.

4. POSSIBLE SIDE EFFECTS

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

Seek medical advice immediately if you develop the following symptoms:

• Allergic reactions: swelling of the face, throat or tongue, fever, difficulty in breathing, dizziness
• Severe blistering of the skin, mouth, eyes and genitals (Toxic Epidermal Necrolysis) [TEN]
• 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)

Side effects (frequency not known)

• Skin and lip cancer (non-melanoma skin cancer)
• Headache
• Feeling of weakness
• Tiredness (fatigue), mental numbness (stupor), sleepiness or drowsiness (somnolence)
• Generally feeling unwell (malaise),
• Fainting (syncope), dizziness, vertigo (sensation of whirling and loss of balance, feeling giddy)
• Disrupted heart rhythm (arrhythmias), faster heartbeat (tachycardia), feeling your heartbeat (palpitations), partial heart block (electrical pulses that control the beating of the heart are disrupted) developing into complete heart block
• Digitalis Toxicity (a poisoning that occurs when you take too much digitalis [also known as digoxin or digitoxin], a medication used to treat heart conditions)
• Low blood pressure (hypotension)
• Chest pain (angina pectoris)
• Loss of appetite (anorexia), disturbed sense of taste, appetite changes, inflammation of the salivary glands (sialadenitis)
• Feeling or being sick (nausea, vomiting)
• Diarrhoea
• Constipation
• Stomach pain, cramping or irritation, feeling of a full stomach, feeling bloated/wind (flatulence), hiccups, activation of pre-existing stomach ulcer, indigestion (dyspepsia)

• Inflammation of the pancreas (pancreatitis), bleeding in the stomach and intestine

  • Thirst, dehydration, dry mouth
  • Increased blood levels of potassium
  • Electrolyte imbalance (electrolytes are minerals such as calcium, chloride, magnesium, phosphate, potassium, and sodium. For the body to function properly, certain minerals need to be maintained in an even balance)
  • Low blood levels of sodium (hyponatraemia)
  • Pain and swelling in one or more joints (gout)
  • Rash, severe itching (pruritus), skin rashes with the formation of wheals (urticaria)
  • Flushing
  • Excessive sweating (diaphoresis), fever
  • Leg ache, muscle cramps, chest/back/joint pain, neck/shoulder ache, pain in arms &/or legs
  • Tingling or numbness in the hands or feet (paraesthesia)
  • Difficulty in sleeping (insomnia), restlessness
  • Nervousness
  • Shakiness (tremors)
  • Mental confusion
  • Depression
  • Shortness of breath or difficulty in breathing (dyspnoea), pneumonitis (inflammation of the lungs), excess collection of watery fluid in the lungs (pulmonary oedema), cough, blocked nose (nasal congestion)
  • Visual disturbances including a condition in which all objects appear to have a yellowish tinge to them (xanthopsia), blurred vision, increased pressure inside the eye
  • Inability to maintain an erection (impotence) which occurs early in the course of treatment and is reversible on withdrawal of treatment, decreased libido
  • Painful urination (dysuria), a need to wake and pass urine at night (nocturia), unintentional passing of urine (incontinence), increased production of urine (polyuria), urinary frequency, bladder spasm, glucose in the urine (glycoscuria)
  • Kidney problems including kidney failure, inflammation of the kidney (interstitial nephritis)
  • Liver problems including yellowing of the skin or whites of the eyes (jaundice)
  • Hair loss (alopecia)
  • Disorder of the brain (encephalopathy)
  • Ringing in the ears (tinnitus)
  • Increased blood sugar levels (hyperglycaemia)
  • High level of uric acid in the blood (hyperuricaemia)
  • Abnormally low levels of potassium in blood (hypokalaemia)
  • High levels of calcium in the blood (hypercalcaemia)
  • Abnormal sensitivity of the skin to sunlight (photosensitivity)
  • Severe reduction in blood cells which can cause weakness, bruising or make infections more likely (aplastic anaemia)
  • Reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia)
  • Reduction in blood cells which may increase the risk of bleeding or bruising (thrombocytopenia) and/or make infections more likely (leucopenia, neutropenia, agranulocytosis)
  • Inflammation and damage of the blood vessel walls that also affects the skin (necrotising angiitis, vasculitis, purpura)
  • Acute Respiratory Distress Syndrome (ARDS) (signs include severe shortness of breath, fever, weakness, and confusion) – very rare side effect.

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 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 this medicine out of the sight and reach of children.

Do not store the tablets above 25°C. Keep them in the original pack. Do not take these tablets after the expiry date shown on the pack. 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 Co-Amilozide Tablets contain

The active substances are 5.68mg Amiloride Hydrochloride as the dihydrate and 50mg Hydrochlorothiazide. The other ingredients are Lactose Monohydrate, Calcium Hydrogen Phosphate, Maize Starch, Talc, Sodium Starch Glycollate, Magnesium Stearate and colour Sunset Yellow Lake (E110).

Sodium content per tablet: Maximum 0.3mg.

What Co-Amilozide Tablets look like and contents of the pack

Co-Amilozide Tablets are pale peach, flat bevelled edge tablets with 'RX' on one face, breakline and tablet code '237' on reverse.

Pack sizes: Container packs of 28, 100, 250, 500, 1000 tablets and blister packs of 28 and 30 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

RxFarma, Colonial Way, Watford, Hertfordshire, WD24 4YR

Manufacturer:

RX Farma Limited, Unit 3, Colonial Way, Watford, Hertfordshire, WD24 4YR, United Kingdom.

This leaflet was last revised in June 2026