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PATIENT INFORMATION LEAFLET

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

In this leaflet:
□	What this medicine is and what it is used for	£	Possible side effects
c	Before you take		How to store
y	How to take	y	Further information

|1 What this medicine is and what it is used for

Lisinopril + Hydrochlorothiazide Tablets contain Lisinopril Dihydrate and Hydrochlorothiazide. Lisinopril Dihydrate is one of a group of medicines known as 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 is one of a group of medicines known as 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 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.

|2l Before you take

Do not take Lisinopril + Hydrochlorothiazide

Tablets:

•    If you are allergic (hypersensitive) to Lisinopril Dihydrate, Hydrochlorothiazide, other Sulphonamides, other ACE Inhibitors or any of the other ingredients in the tablets (these are listed in Section 6, Further information)

•    If you have suffered from red, itchy swelling of the eyes, lips, tongue, throat or hands linked to previous treatment with an ACE Inhibitor (Angioneurotic Oedema)

•    If you suffer from fluid retention (Idiopathic Angiodema)

•    If you suffer from severe kidney problems or narrowing of the arteries in the kidneys

•    If you suffer from severe liver problems

•    If you are more than 3 months pregnant.

(It is also better to avoid Lisinopril + Hydrochlorothiazide in early pregnancy - see pregnancy section)

Take special care with Lisinopril +

Hydrochlorothiazide - Tell your doctor if any

of the following apply to you:

•    If you are due to have a surgical operation. You should make sure that the anaesthetist is aware you are taking Lisinopril + Hydrochlorothiazide.

•    If you are suffering from dehydration as a result of diuretic treatment, low salt diet, dialysis, diarrhoea or vomiting

•    If you suffer from heart failure or other heart problems

•    If you suffer from kidney problems

•    If you suffer from liver problems

•    If you are on dialysis

•    If you are diabetic

•    If you are currently suffering from a cough

•    You must tell your doctor if you think you are (or might become) pregnant. Lisinopril + Hydrochlorothiazide 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 pregnancy section)

Taking other medicines

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

Medicines which may interact with Lisinopril + Hydrochlorothiazide

• If you are due to have a surgical procedure. You should make sure that the anaesthetist is aware you are using Lisinopril + Hydrochlorothiazide Tablets

•    Medicines used to treat high blood pressure e.g. Sotalol, Propanolol, Verapamil (Beta Blockers/Calcium Channel Blockers)

•    Medicines used to increase frequency of urination e.g. Spironolactone, Triamterence, Amiloride (Diuretics)

•    Medicines used to treat depression e.g. Amitriptyline (Tricyclic Antidepressant)

•    Medicines used to treat mood disorders e.g. Lithium (Antipsychotic)

•    Medicines used to treat diabetes e.g. insulin

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

•    Medicines used to treat infections e.g. Trimethoprim, Amphotericin B

•    Calcium supplements e.g. Adcal, Cacit,

Cal ci chew

•    Medicines used to treat irregular heartbeats e.g. Procainamide (Cardiac Glycosides)

•    Medicines used to control cholesterol levels e.g. Cholestyramine, Colestipol, Lovastatin

•    Medicines used to reduce inflammation e.g. Prednisolone, Corticotropin (Corticosteroids)

•    Medicines used to treat gout e.g. Allopurinol, Probenecid

•    Muscle relaxants e.g. Tubocurarine

•    Non Steroidal Anti-Inflammatory Drugs (NSAIDs) e.g. Acetylsalicylic Acid

•    Potassium-containing supplements or salt substitutes

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

•    Medicines used to treat constipation e.g. Bisacodyl, Senna (Stimulant Laxatives)

Taking Lisinopril + Hydrochlorothiazide with food and drink

During treatment with Lisinopril + Hydrochlorothiazide, it is advisable not to drink alcohol.

Pregnancy and breast-feeding Pregnancy

You must tell your doctor if you are (or might become) pregnant. Your doctor will normally advise you to stop taking Lisinopril + Hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Lisinopril + Hydrochlorothiazide. Lisinopril + Hydrochlorothiazide 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.

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Lisinopril + Hydrochlorothiazide 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 or using machinery

Lisinopril + Hydrochlorothiazide Tablets can cause dizziness and fainting. This is more likely to occur at the start of treatment, when the dose is changed or if you drink alcohol. If this is experienced it is necessary to avoid driving or operating machinery or pursuing any activity in which full attention is required.

Important information about some of the ingredients of Lisinopril+

Hydrochlorothiazide

Lisinopril + Hydrochlorothiazide contains mannitol. This may have a mild laxative effect.

continued...

\3 How to take

Always take Lisinopril + Hydrochlorothiazide Tablets as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

• Lisinopril + Hydrochlorothiazide Tablets should be swallowed whole and with sufficient fluid (e.g. water).

Adults & Elderly

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

Patients with kidney problems

The recommended starting dose of Lisinopril is 5-10 mg.

Diuretic-treated patients

The diuretic should be discontinued 2 to 3 days before taking Lisinopril + Hydrochlorothiazide. If this is not possible, treatment should be started with Lisinopril alone, in a 2.5 mg dose. These patients should be carefully monitored.

Children

Lisinopril + Hydrochlorothiazide Tablets are not recommended for children.

Do not change your dose unless your doctor tells you to do so.

If you taken more Lisinopril + Hydrochlorothiazide 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.

If you forget to take Lisinopril + Hydrochlorothiazide Tablets

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 tablet.

If you stop taking/using Lisinopril + Hydrochlorothiazide Tablets

It is important that you keep on taking Lisinopril + Hydrochlorothiazide Tablets until the prescribed dose has finished. Do not stop taking the tablets even though you may feel better. Do not stop or change your treatment before talking to your doctor.

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

Possible side effects

Like all medicines, Lisinopril + Hydrochlorothiazide Tablets can cause side effects, although not everybody gets them.

Stop taking Lisinopril + Hydrochlorothiazide Tablets and seek medical advice immediately if you develop the following:

•    Severe allergic reaction e.g. itching, rash, wheezing, swelling of hands, face, lips, tongue, mouth, throat or eyelids (Anaphylaxis)

Common side effects (affects 1-10 users in 100)

•    Dizziness (Vertigo)

•    Headache

•    Feeling tired (Fatigue)

•    Dry and persistent cough

•    Low blood pressure (Hypotension)

Uncommon side effects (affects 1-100 users in 1000)

•    Diarrhoea

•    Feeling sick (Nausea)

•    Being sick (Vomiting)

•    Indigestion (Dyspepsia)

•    Inflammation of the pancreas (Pancreatitis)

•    Dry mouth (Xerostomia)

•    Skin rashes

•    Gout

•    Feeling your heartbeat (Palpitations)

•    Chest pain

•    Muscular spasm

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

•    General weakness (Asthenia)

•    Inability to maintain an erection (Impotence)

Other side effects

•    Fever

•    Muscle pain (Myalgia)

•    Pain in the joints (Arthralgia)

•    Abnormal sensitivity of the skin to sunlight (Photosensitisation)

•    Loss of appetite

•    Constipation

•    Liver failure or other liver disorders including jaundice (yellowing of skin and eyes)

•    Inflammation of the salivary glands (Sialoadenitis)

•    Blurred/disturbed vision

•    Skin rashes with the formation of wheals (Urticaria)

•    Severe skin disorders including Stevens-Johnson Syndrome

•    Shortness of breath or difficulty in breathing

•    Pneumonia

•    High blood sugar levels (Hyperglycaemia)

•    Restlessness

•    Kidney failure

•    Disrupted heart rhythm (Arrhythmia)

•    Heart attack (Myocardial Infarction)

•    Stroke

•    Faster heartbeat (Tachycardia)

•    Reddening of the face

•    Tingling or numbness in the fingers, toes, ears or nose (Raynauds Phenomenon)

•    Abdominal pain

•    Mood changes

•    Confusion

•    Abnormal sense of taste (Dysgeusia)

•    Sleep disorders

•    Cold-like symptoms; sneezing, itchiness, blocked/runny nose (Rhinitis/Sinusitis)

•    Hair loss (Alopecia)

•    Excessive sweating (Diaphoresis)

•    Itching (Pruritus)

•    Passing urine less frequently (Oliguria)

•    Looking pale and feeling tired (Anaemia)

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store

Keep out of the reach and sight of children. Store in the original package.

Do not use Lisinopril + Hydrochlorothiazide Tablets after the expiry date which is stated on the carton/pouch after "EXP". 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 Further information

What Lisinopril + Hydrochlorothiazide contains:

The active substances are Lisinopril Dihydrate and Hydrochlorothiazide

Other ingredients are:

Calcium hydrogenphosphate dihydrate, croscarmellose sodium, mannitol, maize starch, magnesium stearate and ferric oxide red (E 172).

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

Lisinopril + Hydrochlorothiazide Tablets are pink, round, biconvex tablets with a score notch on one side.

Lisinopril + Hydrochlorothiazide are available in:

Lisinopril + Hydrochlorothiazide Tablets are available in packs of: 14, 28, 30, 50, 56, 98, 100, 400

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Roger Oakes Ltd Allstoe House, Church Lane Greetham, Rutland LE15 7NF

Manufacturer:

Salutas Pharma GmbH,

Otto-Von-Guericke-Allee 1,

39179 Barleben,

Germany

Product Licence Number:

Lisinopril + Hydrochlorothiazide 10/12.5mg Tablets

PL 11311/0235

Lisinopril + Hydrochlorothiazide 20/12.5mg Tablets

PL 11311/0236

The leaflet was revised in February 2011

Hard to Read? Phone 0800 970 6115 for help

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