Do not take Zestoretic:

• if you are allergic to lisinopril or hydrochlorothiazide or any of the other ingredients of Zestoretic (listed in section 6).
• if you are allergic to ACE inhibitor or sulphonamide medicines. If you are not sure if this applies to you, please ask your doctor.
• if you have ever had sudden swelling of the hands, feet, ankles, face, lips, tongue or throat, especially if this followed treatment with an ACE inhibitor. It may also have been difficult to swallow or breathe.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased.
• if you have hereditary angioedema (a condition that makes you more prone to the swelling described above). If you are not sure if this applies to you, please ask your doctor.
• if you have severe kidney problems.
• if you have stopped passing water (urine).
• if you have severe liver problems.
• if you are more than 3 months pregnant. (It is also better to avoid Zestoretic in early pregnancy – see the sections on ‘Pregnancy and breast-feeding’).
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Do not take Zestoretic if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Zestoretic.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zestoretic:

• 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 Zestoretic.
• if you have a narrowing (stenosis) of the aorta (an artery in your heart), the heart valves (mitral valves) or the kidney artery.
• if you have an increase in the thickness of the heart muscle (known as hypertrophic cardiomyopathy).
• if you have problems with your blood vessels (collagen vascular disease).
• if you have low blood pressure. You may notice this as feeling dizzy or light-headed, especially when standing up.
• if you have kidney problems or you are having kidney dialysis or you have had a kidney transplant.
• if you have liver problems.
• if you have diabetes.
• 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. See also information under the heading “Do not take Zestoretic”.

• if you have recently had diarrhoea or vomiting (being sick).
• if your doctor has told you to control the amount of salt in your diet.
• if you have high levels of cholesterol and you are having a treatment called ‘LDL apheresis’.
• if you have ever had a condition called systemic lupus erythematosus (SLE).
• if you are of black origin as Zestoretic may be less effective. You may also more readily get the side effect ‘angioedema’ (a severe allergic reaction with swelling of the hands, feet, ankles, face, lips, tongue or throat).
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in area such as the throat) is increased:
  • temsirolimus, sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to avoid rejection of transplanted organs and for cancer).
  • Racecadotril, a medicine used to treat diarrhoea;
  • Vildagliptin, a medicine used to treat diabetes.
• 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 Zestoretic. 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.

You must tell your doctor if you think you are (or might become) pregnant. Zestoretic 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 (see the sections on ‘Pregnancy and breast-feeding’).

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Zestoretic.

Treatment for allergies such as insect stings

Tell your doctor if you are having or are going to have treatment to lower the effects of an allergy such as insect stings (desensitisation treatment). If you take Zestoretic while you are having this treatment, it may cause a severe allergic reaction.

Operations

If you are going to have an operation (including dental surgery) tell the doctor or dentist that you are taking Zestoretic. This is because you can get low blood pressure (hypotension) if you are given certain local or general anaesthetics while you are taking Zestoretic.

Other medicines and Zestoretic

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Zestoretic can affect the way some medicines work and some medicines can have an effect on Zestoretic. Your doctor may need to change your dose and/or to take other precautions.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Other medicines for treatment of high blood pressure (antihypertensives).
• An angiotensin II receptor blocker (ARB) or aliskiren, (see also information under the headings “Do not take Zestoretic” and “Warnings and precautions”).
• Medicines associated with low blood potassium (hypokalaemia) such as other diuretics (“water tablets” including those which conserve potassium, laxatives, corticosteroids (e.g. prednisone), ACTH (A hormone), amphotericin (an antifungal medicine) and salicylic acid derivatives.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen or indomethacin, used to treat muscle pain or arthritis.
• Medicines for depression (tricyclic and tetracyclic antidepressants).
• Medicines for mental problems such as lithium.
• Aspirin (acetylsalicylic acid), if you are taking more than 3 grams each day.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in your blood (e.g. trimethoprim and co-trimoxazole for infections caused by bacteria; ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots).
• Calcium salts or Vitamin D supplements.
• Medicines for diabetes (insulin and oral antidiabetics such as sulphonylureas). Your dose of antidiabetic medicine may need to be changed when taking thiazide diuretics.
• Medicines to treat asthma.
• Medicines to treat nose or sinus congestion or other cold remedies (including those you can buy in the pharmacy).
• Medicines to suppress the body’s immune response (immunosuppressants, such as ciclosporin).
• Allopurinol (for gout).
• Medicines for uneven heart beat problems (such as procainamide).
• Heart medicines (e.g. digoxin) or other medicines to control the rhythm of your heart.
• Gold injections (such as sodium aurothiomalate), usually used to treat rheumatoid arthritis.
• Amphotericin B injection (to treat fungal infections).
• Carbenoxolone (to treat ulcers or inflammation in the gullet or in and around the mouth).
• Corticosteroids (steroid medicines).
• Corticotropin (a hormone).
• Medicines to treat constipation (stimulant laxatives).
• Colestyramine and colestipol (to lower cholesterol, prevent diarrhoea or reduce itching).
• Muscle relaxants such as tubocurarine.
• Trimethoprim (an antibiotic).
• Sotalol (a beta-blocker).
• Lovastatin (to lower cholesterol).
• Dextran sulphate (used in the treatment called ‘LDL apheresis’ to lower cholesterol).

The following medicines may increase the risk of angioedema (signs of angioedema include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing):

• Medicines to break up blood clots (tissue plasminogen activator), usually given in hospital.
• Medicines which are most often used to avoid rejection of transplanted organs (temsirolimus, sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section 2 “Warnings and precautions”.
• Racecadotril used to treat diarrhoea.
• Vildagliptin, a medicine used to treat diabetes.
• Other medicines known to have an effect on the heart called Torsades de pointes.

Low blood pressure may be aggravated by alcohol, barbiturates or anaesthetics. You may notice dizziness when standing up.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Zestoretic before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Zestoretic. Zestoretic 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. Zestoretic 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 newborn, or was born prematurely.

Driving and using machines

• This medicine may cause occasional dizziness or tiredness which may have an effect on your ability to drive or use machines, especially at the start of treatment or when the dose is adjusted, or in combination with alcohol. If this happens to you, do not drive or use any tools or machines.
• You must wait to see how your medicine affects you before trying these activities.