CO-AMILOZIDE TABLETS 2.5/25 - patient leaflet, side effects, dosage

PACKAGE LEAFLET: INFORMATION FOR THE USER

CO-AMLOZIDE TABLETS 2.5/25 (Hydrochlorot­hiazide and Amiloride Hydrochloride)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have 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 symptoms 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 Co-amilozide Tablets 2.5/25 is and what it is used for

• 2. What you need to know before you take Co-amilozide Tablets 2.5/25

• 3. How to take Co-amilozide Tablets 2.5/25

• 4. Possible side-effects

• 5. How to store Co-amilozide Tablets 2.5/25

• 6. Contents of the pack and other information

1. what co-amilozide tablets 2.5/25 is and what it is used for

“Co-amilozide” is the generic (common) name for a combination of two active ingredients, the potassium-conserving diuretic amiloride hydrochloride and the thiazide diuretic hydrochlorothi­azide.

A diuretic is a substance that increases the amount of urine produced by your kidneys. This lowers the blood pressure or remove excess water from your body.

Co-amilozide is used to treat:

• high blood pressure
• congestive heart failure (a condition where there is ineffective pumping of the heart, leading to accumulation of fluid in the lungs)
• accumulation of fluid (oedema and ascites) associated with a liver disease called cirrhosis.

2. what you need to know before you take co-amilozide tablets 2.5/25

Do not take Co-amilozide tablets 2.5/25 if you:

• are allergic to amiloride hydrochloride, hydrochlorothiazide or to any of the other ingredients of this medicines (listed in section 6 of this leaflet);
• are allergic to a type of antibiotic called sulfonamide, such as sulfamethoxazole
• are allergic to thiazide diuretics or related sulphonamide-derived drugs;
• suffer from anuria (inability to produce urine);
• suffer from acute renal (kidney) insufficiency or rapidly advancing renal impairment; suffer from kidney damage caused by diabetes (diabetic nephropathy);
• have seriously reduced hepatic (liver) function;
• suffer from gout;
• have been told by your doctor you have high levels of urea, creatinine, potassium or calcium in your blood (serum levels above 5.5mmol/l);
• are taking any other potassium-sparing drugs (diuretic) such as eplerenone, spironolactone or triamterene;
• are taking potassium supplements, medicine containing potassium or you eat potassium or you eat potassium-rich foods;
• have diabetes (a high blood sugar level);
• are allergic to acetazolamide which is a diuretic used to remove fluid from the body and to treat high pressure in the eye (glaucoma), heart problems and sometimes fits or epilepsy;
• have Addison’s disease.

Do not take Co-amilozide tablets 2.5/25 if any of the above applies to you. If you are not sure talk to your doctor or pharmacist before taking Co-amilozide tablets 2.5/25.

Warning and precautions

• suffer from kidney or liver problems
• suffer from diabetes
• 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 tablets 2.5/25. 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
• have been told by your doctor you have high levels of uric acid, cholesterol or triglycerides (a type of cholesterol) in your blood
• are taking digitalis such as digoxin- used for heart failure and abnormal heart beat
• are being given fluids by a tube inserted into one of your veins
• have recently suffered from severe vomiting or diarrhoea
• have Systemic Lupus Erythematosus
• are elderly
• have ever suffered from gout
• 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 tablets 2.5/25.

If you are not sure talk to your doctor or pharmacist before taking Co-amilozide tablets 2.5/25.

Children and adolescents

Do not give this medicine to children under 18 years of age as limited data is available.

Other medicines and Co-amilozide tablets 2.5/25

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines. This is because Co-amilozide tablets 2.5/25 can affect the way some other medicines work. Also some other medicines can affect the way Co-amilozide tablets 2.5/25 work.

It is especially important that your doctor knows if you are taking:

• any other medicine(s) used to treat high blood pressure, including angiotensin converting enzyme inhibitors (ACE inhibitors), enalapril or heart problems;
• angiotensin II receptor antagonists such as losartan- used to treat high blood pressure or diabetics with kidney damage
• a non-steroidal anti-inflammatory agent (NSAIDs), such as aspirin or ibuprofen, used to relieve pain, fever and the symptoms of arthritis;
• a narcotic painkiller, such as codeine, dihydrocodeine, dextropropoxyphene, diamorphine, morphine, pentazocine and pethidine;
• medicines injected for allergic reactions such as adrenaline (epinephrine);
• ACTH to test whether your adrenal glands are working properly;
• a medicine for diabetes, such as insulin or chlorpropamide;
• a barbiturate used to treat insomnia or to reduce anxiety;
• cholestyramine or colestipol, which are used to reduce blood cholesterol levels (hyperlipidaemia);
• steroids- used to treat lots of different conditions such as rheumatism, arthritis, allergic conditions, skin problems, asthma or a type of blood disorder;
• ciclosporin (cyclosporin), which is used for rheumatoid arthritis and to prevent rejection after transplant surgery;
• lithium to treat depression;
• tacrolimus -used after a liver or kidney transplant to prevent rejection;
• ‘non-depolarising’ muscle relaxants such as tubocurarine.

In addition, if you are going to have an operation, make sure the doctor treating you knows you are taking Co-amilozide.

Tests while you are taking Co-amilozide tablets 2.5/25

When you are on this medication it may affect some tests on blood or urine samples. Please remind your doctor you are taking Co-amilozide tablets 2.5/25 if he or she wants you to have any tests.

If you have diabetes or your doctor suspects you have diabetes, you may need to have some tests before receiving treatment with Co-amilozide tablets 2.5/25.

Co-amilozide tablets 2.5/25 with food, drink and alcohol

Your doctor may have asked you to change your diet slightly and not to eat certain foods which contain a lot of potassium. These foods include milk, bananas, raisins and prunes. Your doctor will tell you what food you should not eat. If you are unsure about what food you should avoid, ask your doctor before taking Co-amilozide tablets 2.5/25.

Your doctor may have told you that you should keep alcohol intake to a minimum while you are taking Co-amilozide tablets 2.5/25. Alcohol may increase the effects of Co-amilozide tablets 2.5/25 so that you feel dizzy or light-headed when you stand up quickly.

Pregnancy and breast-feeding

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.

Pregnancy

Usually, your doctor will advice you to take another medicine instead Co-amilozide tablets 2.5/25, as Co-amilozide tablets 2.5/25 is not recommended during pregnancy. This is because Co-amilozide tablets 2.5/25 crosses the placenta and its use after the third month of pregnancy may cause potentially harmful foetal and neonatal effects.

Breastfeeding

Co-amilozide tablets 2.5/25 is not recommended for mothers who are breast-feeding.

Driving and using machines

This medicine may make you feel tired or dizzy. Do not drive or operate machinery until you have discussed this with your doctor or you know if you are affected.

Co-amilozide tablets 2.5/25 contains 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.

3. how to take co-amilozide tablets 2.5/25

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You should take this medicine by mouth. The dose varies according to the nature and severity of your condition.

The recommended doses are:

Hypertension (High blood pressure): initially 1 tablet daily, increasing if necessary to a maximum of 2 tablets daily. Your doctor may spread out the doses or give it all together as a single dose.

Congestive heart failure: initially 1 tablet daily, your doctor may change your dose, increasing if necessary to a maximum of 4 tablets daily.

Oedema and ascites in cirrhosis of the liver: initially 2 tablets daily, your doctor may change your dose, increasing if necessary to a maximum of 4 tablets daily.

If you take more Co-amilozide Tablets 2.5/25 than you should contact your doctor immediately, or go to the nearest hospital casualty department.

If you forget to take Co-amilozide Tablets 2.5/25, just take the next dose when it is due – do not take a double dose to make up for a missed dose.

If you stop taking Co-amilozide tablets 2.5/25

Do not stop taking Co-amilozide tablets 2.5/25 without speaking 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. The following side effects have been reported:

Stop taking Co-amilozide tablets 2.5/25 and see a doctor straight away, if you notice any of the following serious side effects that may rarely occur. You may need urgent medical treatment:

• Allergic reactions – the signs may include inflamed blood vessels, problems with breathing or swallowing, collapse, redness, blisters, peeling skin, muscle pains, chills, a general feeling of being unwell, ulcerated mouth, eyes and genitals,
• irregular heart beat of your heart that can lead to fainting and dizziness, palpitations (a sensation that the heart is racing, pounding, fluttering or skipping a beat, often bothersome, but hardly ever a sign of heart disease),
• fast heart beat, chest pains (angina),
• bleeding from your gut – signs may include blood in your faeces,
• liver problems such as jaundice – signs may include yellowing of the skin and /or whites of the eyes.

Other side effects include:

Allergic reactions: purplish or reddish-brown spots, skin irritation, increased sensitivity to sunlight and a nettle like rash (urticaria).

Heart and circulatory system: feeling light-headedness when standing up quickly.

Blood: anaemia (which can cause tiredness and a loss of colour from the skin), other disorders of the blood, which can cause fever, sore throat or prolonged bleeding after injury, change in the levels of various chemicals in the blood which are usually detected by blood or urine tests.

Digestive system: indigestion, feeling or being sick, stomach ache and cramps, diarrhoea, constipation, wind, abdominal fullness, loss of appetite, hiccups, thirst , pancreatitis (swelling of the pancreas, resulting in severe abdominal pain), swelling of the salivary glands, your mouth may become dry, a bad taste in your mouth.

Skin/hair: rash, itching, flushing, sweating, hair loss, skin and lip cancer (non- melanoma skin cancer).

Muscles and joints: joint pain, pain in the fingers and toes, gout, neck, shoulder and back pain, aching legs, muscle cramps.

Nervous system: dizziness, feeling like you are spinning (vertigo), pins and needles, insomnia, sleepiness, nervousness, confusion, depression or restlessness, stupor (a state of near-unconsciousness or insensibility), a type of brain disorder called encephalopathy, feeling shaky( tremors), headache, blackout.

Respiratory: cough, difficulty in breathing, blocked nose, pneumonitis (i.e. inflammation of the lung tissue), pulmonary oedema (i.e. excess fluid in the lungs).

Eyes or ears: an increase in pressure within the eye which is usually picked up in eye examinations, changes in the vision, 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), ringing in the ears, xanthopsia (a colour vision deficiency in which there is a predominance of yellow in vision).

Urogenital: difficulty or pain urinating, an increase in the amount of urine passed, contractions of the bladder which can lead to an increased frequency of urinating, passing urine at night, incontinence (loss of bladder control, varying from a slight loss of urine after sneezing, coughing or laughing, to complete inability to control urination), kidney problems that can lead to a reduction in the amount of urine passed.

Sexual: decreased sex drive, impotence.

General/Other: weakness, tiredness, a general feeling of being unwell, dehydration.

If you experience these or any other unwanted effects not mentioned above, please inform your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or 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 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 2.5/25

Keep this medicine out of the sight and reach of children

Store in a dry place below 25°C.

Do not use this medicine after the expiry date, which is stated 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.

6. contents of the pack and other information

Co-Amilozide Tablets 2.5/25 contains

The active substances are amiloride hydrochloride and hydrochlorothi­azide.

The other ingredients of the tablet are rice starch, microcrystalline cellulose, lactose, magnesium stearate, povidone and talc.

Each tablet contains 2.5 mg anhydrous amiloride hydrochloride and 25 mg hydrochlorothi­azide.

What Co-Amilozide Tablets 2.5/25 looks like and contents of the pack

Co-amilozide Tablets 2.5/25 are white or almost white tablets.

Co-amilozide Tablets 2.5/25 are supplied in packs of 30 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Genethics Europe Limited, 41–43 Klimentos, Klimentos Tower, Nicosia 1061, Cyprus

Manufacturer:

Medevale Pharma Services Limited, Ashton-Under-Lyne, Lancashire OL7 9RR

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 11/2020.