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PATIENT INFORMATION LEAFLET

Lisinopril + Hydrochlorothiazide 10/12.5mg and 20/12.5mg Tablets

What Lisinopril + HCT is and what it is used for

Lisinopril + Hydrochlorothiazide tablets contain Lisinopril Dihydrate and Hydrochlorothiazide (HCT). Lisinopril Dihydrate belongs to a group of medicines called ACE (Angiotensin-Converting Enzyme) Inhibitors. These work by expanding your blood vessels making it easier for your heart to pump blood to your body. Hydrochlorothiazide (HCT) belongs to a group of medicines called diuretics. 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 circulating in your body.

Lisinopril + Hydrochlorothiazide tablets (referred to as Lisinopril + HCT throughout this leaflet) are used in the treatment or prevention of high blood pressure (hypertension). It is intended for patients whose blood pressure is not adequately controlled on Lisinopril or Hydrochlorothiazide alone.

^ What you need to know before you take Lisinopril + HCT

Do not take Lisinopril + HCT if:

•    You are allergic (hypersensitive) to Lisinopril Dihydrate, Hydrochlorothiazide, other sulphonamides, other ACE Inhibitors or any of the other ingredients of this medicine (see Section 6 "Contents of the pack and other information”)

•    You suffer from a failure of the kidneys to produce urine (anuria)

•    You have a narrowing of the aortic valve in the heart, restricting the blood flow (aortic stenosis)

•    You have abnormally high levels of potassium in the blood (hyperkalaemia)

•    You have a history of suffering from swelling of the deeper layers of the skin caused by a build-up of fluid relating to previous treatment with an ACE Inhibitor (angioneurotic oedema)

•    You suffer from an inherited swelling of the deeper layers of the skin caused by a build-up of fluid or without an identifiable cause (hereditary or idiopathic angiodema)

•    You suffer from severe kidney disorders or narrowing of the arteries in the kidneys

•    You suffer from severe liver disorders

•    You are more than 3 months pregnant (it is also better to avoid Lisinopril + HCT in early pregnancy -see "Pregnancy and breast-feeding” section)

•    You have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren (see "Other medicines and Lisinopril + HCT” section)

Warnings and precautions

Talk to your doctor before taking Lisinopril + HCT

•    If you are due to have surgery, you should make sure that the anaesthetist is aware you are taking Lisinopril + HCT

•    If you are suffering from dehydration (symptoms of this include; dry mouth, thirst, weakness, lack of energy [lethargy], drowsiness, muscle pain or cramps, low blood pressure [hypotension], decreased production of urine [oliguria], faster heartbeat [tachycardia], feeling [nausea] or being [vomiting] sick) as a result of diuretic treatment, low salt diet, dialysis, diarrhoea or being sick (vomiting) or have severe renin-dependant high blood pressure (hypertension)

•    If you suffer from heart disease or other heart disorders

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

o    An angiotensin II receptor blocker (ARBs)

(also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems o    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 Lisinopril + HCT”

•    If you suffer from kidney disorders or have had a kidney transplant or if you are on dialysis, especially with high-flux dialysis membranes (AN 69)

•    If you are taking a diuretic medicine such as amiloride, as treatment with the diuretic medicine should be discontinued 2 to 3 days before starting Lisinopril + HCT 10/12.5mg. If this is not possible, treatment should be started with Lisinopril alone, in a 5mg dose (see section 3 "How to take Lisinopril + HCT”)

•    If you are having a non-surgical treatment that removes Low-Density Lipoprotein (LDL) cholesterol from the blood by a procedure called LDL apheresis with dextran sulphate

•    If you suffer from liver disorders

•    If you are diabetic, as the dose of your oral anti-diabetic medicine or insulin may need to be adjusted

•    If you are taking potassium-containing supplements or salt substitutes or medicines associated with increases in potassium in the blood e.g. heparin (see "Other medicines and Lisinopril + HCT” section)

•    If you have a history of suffering from swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema). If you are black, you are at higher risk of developing angioedema and Lisinopril may be less effective in lowering blood pressure than in non-black patients

•    If you suffer from long-term inflammation of skin and/or intestines (Systemic Lupus Erythematosus [SLE])

•    If you are receiving treatment to reduce the effects of an allergy (desensitisation) to a bee or wasp sting

•    If you suffer from inflammation or weakness of the connective tissue (collagen vascular disease)

•    If you are taking immunosuppressants, medicines used to reduce the body's immunity when receiving organ transplant e.g. ciclosporin (see "Other medicines and Lisinopril + HCT” section)

•    If you are taking allopurinol, a medicine used to treat gout (see "Other medicines and Lisinopril + HCT” section)

•    If you are taking procainamide, a medicine used to treat irregular heartbeats [digitalis/cardiac glycosides] (see "Other medicines and Lisinopril + HCT” section)

•    If you are currently suffering from a cough

•    If you are taking lithium, a medicine used to treat mood disorders [antipsychotic] (see "Other medicines and Lisinopril + HCT” section)

•    Hydrochlorothiazide could produce a positive result in an anti-doping test

•    If you are pregnant, think you may be pregnant or are planning to have a baby (see "Pregnancy and breast-feeding” section)

Other medicines and Lisinopril + HCT

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.

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings "Do not take Lisinopril + HCT” and "Warnings and precautions”)

Medicines which may interact with or be affected by Lisinopril + HCT:

•    If you are due to have surgery, you should make sure that the anaesthetist is aware you are taking Lisinopril + HCT

•    Potassium-containing supplements or salt substitutes, particularly if you suffer from impaired kidney function or diabetes or medicines associated with increases in potassium in the blood e.g. heparin

•    Lithium, a medicine used to treat mood disorders (antipsychotic)

•    Medicines used to treat diabetes e.g. insulin or oral medicines, as the dose of your anti-diabetic medicine may need to be adjusted

•    Non Steroidal Anti-Inflammatory Drugs (NSAIDs), medicines used to treat certain rheumatic disorders e.g. aspirin, if you are taking more than 3g a day (of aspirin) and indometacin, especially if you are an older person

•    Injectable gold to treat rheumatoid arthritis e.g. sodium aurothiomalate

•    Medicines used to treat gout e.g. allopurinol, probenecid

•    Medicines used to reduce the body's immunity when receiving organ transplant e.g. ciclosporin (immunosuppressants)

•    Medicines used to treat anxiety or sleep disorders such as amobarbital (barbituates)

•    Narcotic pain relievers such as codeine, diamorphine, morphine, pentazocine, pethidine

•    Medicines used to lower cholesterol e.g. lovastatin, cholestyramin, colestipol (Lisinopril + HCT should be taken at least 1 hour before or 4-6 hours after taking these medicines)

•    Medicines used to treat infections e.g. trimethoprim, amphotericin B

•    Medicines used to treat irregular heartbeats e.g. procainamide (digitalis/cardiac glycosides)

•    Sotalol, a medicine used to treat heart rhythm disorders and high blood pressure (beta blocker)

•    Medicines used to treat depression such as amitriptyline (tricyclic antidepressant)

•    Medicines used to reduce inflammation e.g. corticotropin (corticosteroids)

•    Medicines used to treat oral ulcers e.g. carbenoxolone

•    Medicines used to treat constipation such as bisacodyl, senna (stimulant laxatives)

•    Medicines used to treat severe allergic reactions e.g. epinephrine (sympathomimetics)

•    Medicines used to treat angina and heart failure e.g. glyceryl trinitrate, other nitrates and other vasodilators (medicines used to widen the blood vessels)

•    Chemotherapy, used to treat cancer (cytostatic agents)

•    Medicines used to treat indigestion or heartburn (antacids)

•    Calcium supplements such as adcal, cacit, calcichew

•    Muscle relaxants e.g. tubocurarine

•    Medicines used to increase frequency of urination e.g. amiloride (diuretics)

Taking Lisinopril + HCT with food and drink and alcohol

Alcohol may enhance the effect of Lisinopril + HCT and may cause low blood pressure (hypotension), dizziness, tiredness and fainting.

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 for advice before taking this medicine.

Pregnancy

Lisinopril + HCT is not recommended during the first 3 months of pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby.

Unless treatment with Lisinopril + HCT is considered essential, if you are planning to have a baby your doctor should change your treatment to an alternative medicine which is established as safe for use during pregnancy. When pregnancy is diagnosed, treatment with Lisinopril + HCT should be stopped immediately and if appropriate, alternative treatment should be started.

Breast-feeding

The use of Lisinopril + HCT during breast-feeding is not recommended. If Lisinopril + HCT is used during breastfeeding, doses should be kept as low as possible. Alternative treatments which are established as safe for use during breast-feeding are recommended, especially if your baby is newborn or was born prematurely.

Driving and using machines

Lisinopril + HCT may cause low blood pressure (hypotension), dizziness, tiredness and fainting. This is more likely to occur at the start of treatment, when the dose is changed or if you drink alcohol. 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.

Lisinopril + HCT Tablets contain mannitol

This may have a mild laxative effect.

How to take Lisinopril + HCT

Always take Lisinopril + HCT exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

•    These tablets are to be taken orally and should be taken once daily with sufficient fluid

•    The tablets can be divided into equal doses

Adults and older people

•    10/12.5mg tablets are recommended for patients whose blood pressure is not adequately controlled by 10mg of Lisinopril alone.

•    20/12.5mg tablets are recommended for patients whose blood pressure is not adequately controlled by 20mg Lisinopril alone.

•    A maximum daily dose of 40mg Lisinopril/25mg Hydrochlorothiazide should not be exceeded.

Patients being treated with diuretic medicines

Diuretic medicines should be discontinued 2 to 3 days before starting Lisinopril + HCT 10/12.5mg. If this is not possible, treatment should be started with Lisinopril alone, in a 5mg dose. You should be carefully monitored.

Patients with kidney disorders

The recommended starting dose of Lisinopril is 5-10mg. Patients with severe kidney problems should not be treated with the combination of Lisinopril and Hydrochlorothiazide.

Use in children

Lisinopril + HCT Tablets are not recommended for use in children.

If you take more Lisinopril + HCT Tablets than you should

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.

continued...

Symptoms of (Lisinopril) overdose include: severely low blood pressure, circulatory shock, kidney failure, faster/deeper breathing than normal, faster/slower heartbeat, feeling your heartbeat (palpitations), dizziness, anxiety, cough.

Symptoms of (Hydrochlorothiazide) overdose include: excessive urination, loss of consciousness including coma, uncontrolled shaking of the body, impaired or partial loss of voluntary movement, abnormal heartbeat, kidney failure.

If you forget to take Lisinopril + HCT

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose do not take a double dose to make up for a forgotten dose.

If you stop taking Lisinopril + HCT

It is important that you keep taking Lisinopril + HCT for as long as your doctor has told you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

[4 Possible side effects

Like all medicines, Lisinopril + HCT 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

•    Swelling of the face, arms and/or legs, lips, tongue or throat (angioedema)

•    Swelling of the intestines which may cause stomach pain, with or without being sick (intestinal angioedema)

•    Severe blistering of the skin (toxic epidermal necrolysis), mouth, eyes and genitals (Stevens Johnson Syndrome)

•    Long-term inflammation of skin and/or intestines (Systemic Lupus Erythematosus [SLE])

•    Difficulty breathing or dizziness (anaphylaxis)

Common side effects (may affect up to 1 in 10 people)

•    Dizziness

•    Headache

•    Fainting (syncope)

•    Low blood pressure when changing position (orthostatic/postural hypotension)

•    Dry and persistent cough

•    Diarrhoea

•    Being sick (vomiting)

•    Kidney problems

Uncommon side effects (may affect up to 1 in 100 people)

•    Tingling or numbness in the hand or feet (paraesthesia)

•    A sensation of whirling and loss of balance, feeling dizzy or giddy (vertigo)

•    Abnormal sense of taste

•    Sleep disorders

•    Mood changes

•    Depressive symptoms

•    Heart attack (myocardial infarction)

•    Stroke (CerebroVascular Accident [CVA])

•    Feeling your heartbeat (palpitations)

•    Faster heartbeat (tachycardia)

•    Poor circulation causing fingers and toes to be pale and numb (Raynauds Syndrome)

•    Runny nose (rhinitis)

•    Feeling sick (nausea)

•    Abdominal pain

•    Indigestion

•    Increase of liver enzymes and/or bilirubin in the blood

•    Skin rashes

•    Severe itching (pruritus)

•    Inability to maintain an erection (impotence)

•    General weakness (asthenia)

•    Tiredness, weakness or lack energy (fatigue)

•    Increase in nitrogen or creatinine in the blood

•    Abnormally high levels of potassium in blood (hyperkalaemia)

Rare side effects (may affect up to 1 in 1000 people)

•    Small decrease in iron (haemoglobin) in the blood

•    Small decrease in volume of red blood cells in blood (haematocrit)

•    A reduction in white blood cells (neutropenia)

•    Mental confusion

•    Loss of sense of smell (olfactory disturbance)

•    Dry mouth

•    Skin rashes with the formation of wheals (urticaria)

•    Hair loss (alopecia)

•    Skin disease causing scaly pink patches (psoriasis)

•    Excess urea in the blood (uraemia)

•    Severe kidney failure

•    Excessive development of the male breast (gynaecomastia)

•    Syndrome of Inappropriate Antidiuretic Hormone secretion (SIAdH) - Anti-Diuretic Hormone (ADH) is produced by the brain and is stored in and released by the pituitary gland. ADH controls how your body releases and conserves water. SIADH occurs when ADH is produced somewhere other than the brain, which makes it difficult for your body to get rid of excess water. This causes a build-up of fluids as well as abnormally low sodium levels

•    Abnormally low levels of salt (sodium) in blood (hyponatraemia)

Very Rare side effects (may affect up to 1 in 10,000 people)

•    Abnormal condition of the bone marrow in which it is unable to produce normal amounts of red blood cells, white blood cells, and platelets leaving the immune system in a weakened state and vulnerable to infection (bone marrow depression) which may cause pale skin and feeling tired (anaemia) and/or increase the risk of bleeding or bruising (thrombocytopenia) and/or make infections more likely (leucopenia, neutropenia, agranulocytosis)

•    Swollen/enlarged lymph nodes (lymphadenopathy)

•    Autoimmune disease

•    Reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia)

•    Low blood sugar levels (hypoglycaemia)

•    Difficulty in breathing or wheezing or shortness of breath (bronchospasm/allergic alveolitis)

•    Swelling of the lining of the sinuses (sinusitis)

•    Collective symptoms of cough, fever, difficulty breathing and sweating at night (eosinophilic pneumonia)

•    Inflammation of the pancreas (pancreatitis)

•    Liver problems including inflammation of the liver (hepatitis), yellowing of the skin or whites of the eyes (jaundice) or liver failure

•    Excessive sweating (diaphoresis)

•    Blistering of the skin (pemphigus)

•    Fever, general ill feeling, itching, joint aches, multiple skin lesions (erythema multiforme)

•    Inflammatory skin lesions (cutaneous pseudolymphoma)

•    Decreased production of urine (oliguria) or failure of the kidneys to produce urine (anuria)

Other side effects (frequency not known)

•    Hallucinations

•    Reddening of the face (flushing)

•    Chest pain (angina pectoris)

•    Abnormal sensitivity of the skin to sunlight (photosensitivity)

•    Protein in the urine (proteinuria)

•    Collective symptoms which may include one or more of the following:

o    Fever

o    Inflammation of blood vessels (vasculitis)

o    Muscle pain (myalgia)

o    Pain or swelling in the joints (arthralgia)

o    Positive Anti-Nuclear test (ANA)

o    Increased Erythrocyte Sedimentation Rate

(ESR), a blood test that measures how much inflammation is in the body o    Frequent wheezing, breathlessness,

abdominal pain, diarrhoea, fever, cough and rashes due to an increase in certain white blood cells (eosinophilia) o    An increase in certain white blood cells

(leucocytosis) o    Rash

o    Abnormal sensitivity of the skin to sunlight

(photosensitivity) o Other skin conditions

•    Inflammation of the salivary glands (sialoadenitis)

•    Severe reduction in blood cells which can cause weakness, bruising or make infections more likely (aplastic anaemia)

•    Loss of appetite (anorexia)

•    High blood sugar levels (hyperglycaemia)

•    Glucose in the urine (glycosuria)

•    High level of uric acid in the blood (hyperuricaemia)

•    Abnormally low levels of salt (sodium) in blood (hyponatraemia)

•    Abnormally low levels of potassium in blood (hypokalaemia)

•    Abnormally high alkalinity of the blood and body fluids (hypochloremic alkalosis)

•    Abnormally low level of magnesium in the blood (hypomagnesaemia)

•    Increased level of fats (cholesterol and triglyceride) in the blood

•    Gout

•    Restlessness

•    Lightheadedness

•    Condition in which all objects appear to have a yellowish tinge to them (xanthopsia)

•    Blurred/disturbed vision

•    Severe nearsightedness in vision (acute myopia)

•    Sudden eye pain, red eyes and reduced vision caused by pressure inside the eye rising quickly (acute angle-closure glaucoma)

•    Disrupted heart rhythm/irregular heartbeat (cardiac arrhythmias)

•    Inflammation and damage of the blood vessel walls that also affects the skin (necrotising angiitis/vasculitis/cutaneous vasculitis)

•    Inflammation of the lungs (pneumonitis) or an excess collection of watery fluid in the lungs (pulmonary oedema)

•    Stomach irritation

•    Constipation

•    Skin rash caused by small blood vessels bleeding into the skin (purpura)

•    Muscle spasm/weakness

•    General weakness

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 internet at

(www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

How to store Lisinopril + HCT

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the carton/blister after "EXP". 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 to protect the environment.

[g Contents of the pack and other information

What Lisinopril + HCT contains:

•    Each 10/12.5mg tablet contains 10.9mg of Lisinopril Dihydrate equivalent to 10mg of Lisinopril and 12.5mg of Hydrochlorothiazide.

•    Each 20/12.5mg tablet contains 21.78mg of Lisinopril Dihydrate equivalent to 20mg of Lisinopril and 12.5mg of Hydrochlorothiazide.

The other ingredients are: calcium hydrogenphosphate, dihydrate, croscarmellose sodium, mannitol, maize starch, magnesium stearate and ferric oxide red (E 172).

What Lisinopril + HCT looks like and contents of the pack:

•    Lisinopril + HCT 10/12.5mg are pink, round, biconvex tablets with a diameter of 6.9-7.3mm with a score notch on one side.

•    Lisinopril + HCT 20/12.5mg are pink, round, biconvex tablets with a diameter of 8.9-9.3mm with a score notch on one side.

Lisinopril + HCT is available in:

Lisinopril + HCT Tablets are available in packs of: 14,

28, 30, 50, 56, 98, 100, 400 tablets.

Not all pack sizes may be marketed.

Product Licence Numbers:

Lisinopril + HCT 10/12.5mg Tablets: PL 11311/0485 Lisinopril + HCT 20/12.5mg Tablets: PL 11311/0486

Marketing Authorisation Holder:

Tillomed Laboratories Ltd,

3 Howard Road,

Eaton Socon,

St. Neots,

Cambridgeshire,

PE19 8ET,

UK

Manufacturer:

Salutas Pharma GmbH,

Otto-Von-Guericke-Allee 1,

39179 Barleben,

Germany

This leaflet was last revised in October 2014

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