What is Coverdine?

Each of the active ingredients reduces blood pressure and they work together to control your blood pressure:

• Perindopril belongs to a class of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. It works by widening the blood vessels, which makes it easier for your heart to pump blood through them.
• Indapamide is a diuretic (which belongs to a class of medicines called sulphonamide derivatives with an indole ring). Diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced.
• Amlodipine is a calcium channel blockers (which belongs to a class of medicines called dihydropyridines). It works by relaxing blood vessels, so blood passes through easily.

Do not take Coverdine

• if you are allergic to perindopril or other ACE-inhibitors, indapamide or other sulphonamides, amlodipine or other dihydropyridines, or any of the other ingredients of this medicine
• if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes with previous ACE inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema),
• if you have severe liver disease or suffer from a condition called hepatic encephalopathy (disease of the brain caused by liver illness),
• if you are suspected of having untreated decompensated heart failure (severe water retention, difficulty in breathing),
• if you take non antiarrhythmic medicines causing life-threatening irregular beat (torsades de pointes)
• if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where
• your heart is unable to supply enough blood to the body),
• if you suffer from heart failure after a heart attack.
• if you have severe low blood pressure (hypotension),
• if you have low blood potassium,
• if you have severe kidney problems
• if you are receiving dialysis
• if you have moderate kidney problems
• if you are more than 3 months pregnant,
• if you are breastfeeding.
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warning and precaution

Talk to your doctor or pharmacist or nurse before taking Coverdine:

• if you have hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood),
• if you have heart failure or any other heart problems,
• if you have severe increase in blood pressure (hypertensive crisis),
• if you have liver problems,
• if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus or scleroderma,
• if you have atherosclerosis (hardening of the arteries),
• if you need to have a test to check how well your parathyroid gland is working,
• if you suffer from gout,
• if you have diabetes,
• if you are on a salt restricted diet or use salt substitutes which contain potassium (a well-balanced potassium blood level is essential),
• if you take lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with Coverdine should be avoided,
• if you are elderly and your dose needs to be increased,
• if you had photosensitivity reactions,
• if you are black people you may have higher incidence of angiodema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing) and less effective in lowering blood pressure,
• if you are Haemodialysis patients dialysed with high-flux membranes,
• if you have kidney problems,
• if you have too much acid in blood, which may cause an increased rate of breathing,
• if you have cerebral circulatory insufficiency (low blood presure in the brain),
• if you have swelling of the face, lips, mouth , tongue or throat which may cause difficulty in swallowing or breathing (angioedema), which can occur at any time during treatment, stop your treatment immediately and directly contact your doctor,

if you are taking any of the following medicines used to treat high blood pressure:

• an “angiotensin II receptor blocker” (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.
• aliskiren.
• Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
  Your doctor may prescribe you blood tests to check for low sodium or potassium levels or high calcium levels.

You must tell your doctor if you think that you are (or might become) pregnant. Coverdine is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage.

When you are taking Coverdine, you should also inform your doctor:

• if you are to undergo anaesthesia and/or surgery,
• if you have recently suffered from diarrhoea or vomiting, or are dehydrated,
• if you are to undergo dialysis or LDL apheresis (which is removal of cholesterol from your blood by a machine),
• if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings,
• if you are to undergo a medical test that requires injection of an iodinated contrast agent (a substance that makes organs like kidney or stomach visible on an X-ray).

Children and adolescents

• Coverdine should not be given to children and adolescents.

Other medicines and Coverdine

• Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
• Do not take aliskiren (used to treat high blood pressure) if you have diabetes or kidney problems.

You should avoid Coverdine with:

• lithium (used to treat some mental disorders such as mania, manic depressive illness and recurrent depression),
• potassium-sparing drugs (e.g. triamterene, amiloride), potassium supplements or potassium-containing salt substitutes,
• dantrolene (infusion) is also used to treat malignant hyperthermia during anaesthesia (symptoms including very high fever and muscle stiffness),
• estramustine (used in cancer therapy),
• other medicines used to treat high blood pressure: angiotensin-converting-enzyme inhibitor and angiotensin receptor blockers.

Treatment with Coverdine can be affected by other medicines. Your doctor may need to change your dose and/or to take other precautions. Make sure to tell your doctor if you are taking any of the following medicines as special care may be required:

• other medicines for treating high blood pressure, including angiotensin II receptor blocker (ARB), aliskiren, or diuretics,
• potassium-sparing drugs used in the treatment of heart failure : eplerenone and spironolactone at doses between 12,5mg to 50mg by day,
• anaesthetics medicines
• iodinated contrast agent
• bepridil (used to treat angina pectoris),
• moxifloxacine, sparfloxacine (antibiotic: medicine used to treat infection),
• methadone (used to treat addiction)
• dofetilide, ibutilide, bretylium, cisapride, diphemamil, procainamide, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol (for the treatment of an irregular heart beat),
• verapamil, diltiazem (heart medicines)
• digoxin or other cardiac glycosides (for the treatment of heart problems),
• some antibiotics used to treat infections, such as rifampicin, erythromycin, clarithromycin,
• itraconazole, ketoconazole, amphotericin B by injection (to treat fungal disease),
• allopurinol (for the treatment of gout),
• mizolastine, terfenadine or astemizole (antihistamines for hay fever or allergies),
• corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis, and non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high dose salicylates (e.g. acetylsalicylic acid),
• immunosuppressants used for the treatment of auto-immune disorders or following transplant surgery to prevent rejection (e.g. ciclosporin, tacrolimus),
• tetracosactide (to treat Crohn’s disease)
• gold salts, especially with intravenous administration (used to treat symptoms of rheumatoid arthritis),
• halofantrine (used to treat certain types of malaria),
• baclofen used to treat muscle stiffness in diseases such as multiple sclerosis,
• medicines to treat diabetes such as insulin or metformin,
• calcium including calcium supplements,
• stimulant laxatives (e.g. senna),
• medicines for the treatment of cancer,
• vincamine (used to treat symptomatic cognitive disorders in elderly including memory loss),
• medicines to treat mental disorders such as depression, anxiety, schizophrenia...(e.g. tricyclic antidepressants, antipsychotics, imipramine-like antidepressants, neuroleptics),
• pentamidine (used to treat pneumonia),
• ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV).
• hypericum perforatum (St. John’s Wort),
• trimethoprime (for the treatment of infections),
• heparin (medicines used to thin blood),
• medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline),
• nitroglycerin and other nitrates, or other vasodilators that may further reduce blood pressure.

Coverdine with food and drink

• Grapefruit juice and grapefruit should not be consumed by people who are taking Coverdine. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Coverdine.

Pregnancy and breast-feeding

Pregnancy

• You must tell your doctor if you think that you are (or might become) pregnant.
• Your doctor will normally advise you to stop taking Coverdine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Coverdine. Coverdine is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

• Tell your doctor if you are breast-feeding or about to start breast-feeding. Coverdine is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast- feed, especially if your baby is new-born, or was born prematurely.

Driving and using machines

• Coverdine may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy, tired, or give you a headache, do not drive or use machines and contact your doctor immediately.

How to take Coverdine

• 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 tablet with a glass of water preferably in the morning and before a meal. Your doctor will decide on the correct dose for you. This will normally be one tablet once a day.

If you take more Coverdinethan you should

• Taking too many tablets may cause you blood pressure to become low or even dangerously low sometimes associated with nausea, vomiting, cramps, dizziness, sleepiness, mental confusion, oliguria (passing less urine than is normal), anuria (no production or passing of urine). You may fell lightheaded, faint, or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and claimmy and you could loose consciousness. Seek immediate medical attention if you take too many Coverdine tablets.

If you forget to take Coverdine

• It is important to take your medicine every day as regular treatment is more effective. However, If you forget to take a dose of Coverdine, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Coverdine

• As the treatment for high blood pressure is usually life-long, you should discuss with your doctor before stopping this medicinal product.
• If you have any further questions on the use of thismedicine, ask your doctor or pharmacist.

Possible side effects

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

Stop taking the medicinal product and see a doctor immediately, if you experience any of the following side effects:

• sudden wheeziness, chest pain, shortness of breath, or difficulty in breathing, 
• swelling of eyelids, face or lips, 
• swelling of the mouth, tongue and throat, which causes great difficulty breathing, 
• severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome) or other allergic reactions, 
• severe dizziness or fainting, 
• heart attack, 
• unusual fast or abnormal heart beat

Side effects can include:

• Headache, dizziness, palpitations (awareness of your heartbeat), flushing, vertigo, pins and needles, vision disturbances (including double vision), tinnitus (sensation of noises in the ears), light-headedness due to low blood pressure, cough, shortness of breath, gastro-intestinal disorders (nausea, , vomiting, abdominal pain, taste disturbances, , dyspepsia or difficulty of digestion, diarrhea, constipation), allergic reactions (such as skin rashes, itching), cramps, feeling of tiredness, somnolence, ankle swelling (oedema)
• Mood swings, anxiety, depression, sleep disturbances, trembling, hives, fainting, loss of pain sensation, rhinitis (blocked up or runny nose), , altered bowel habits, hair loss, purpura (red pinpoints on skin), skin discoloration, itchy skin, sweating, chest pain, joint or muscle pain, back pain, pain, feeling unwell (malaise), kidney problems, disorder in passing urine, increased need to urinate at night, increased number of times of passing urine, inability to obtain an erection, fever or high temperature, discomfort or enlargement of the breasts in men, weight increase or decrease,
• increase in some white blood cells, high potassium levels in the blood, hypoglycaemia (very low blood sugar level), low sodium levels in the blood, somnolence, rapid heart beat, vasculitis (inflammation of blood vessels), photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA, blister clusters over the skin, swelling of hands, ankles or feet, blood creatinine increased and blood urea increase, fall, dry mouth.
• Confusion, changes in laboratory parameters: Increased level of liver enzymes, high level of serum bilirubin.

References:

https://www.hpra.ie/img/uploaded/swedocuments/2158270.PA0568_024_001.44f0b291-f8

https://www.medicines.ie/medicines/coverdine-31730/patient-info

https://www.medicines.org.uk/emc/product/6223/smpc

https://www.drugs.com/international/coverdine.html

https://www.ndrugs.com/?s=coverdine