LISINOPRIL + HCT 10/12.5MG TABLETS

Active substance: LISINOPRIL DIHYDRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PATIENT INFORMATION LEAFLET

Lisinopril + Hydrochlorothiazide 10/12.5mg and 20/12.5mg Tablets
Please read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you personally and you should not pass it on to other people. It may harm them even if their symptoms are the same as yours. If any of the side effects become serious or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1 2 3

What this medicine is and what it is used for Before you take How to take

4 5 6

Possible side effects How to store 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.

2

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, Calcichew 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...

Hard to Read?

Phone

0800 970 6115

for help
Til-ver.3s

Last modified: 03/11/08

Colour:
Pantone Black CVC

Regulatory: Approved: Signature:
QA:

Size:

148x360mm

Amendments Required: Date:

Task Allocated: Angela Information Provided by: Angela Prepared by: Shehzad PL No. Software: Adobe illustrator 9 (windows) Keyline: Yes
No Rog ver.1

Approved: Signature:

Amendments Required: Date:

General Sales & Marketing:

Tillomed Code: Pharma Code:

XXX XXX

Approved: Signature:

Amendments Required: Date:

Reason for changes : Tillomed Laboratories Ltd, 3 Howard Road Eaton Socon, St Neots, Cambs PE19 8ET, UK

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.

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.

5

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

4

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)

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

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

The leaflet was revised in February 2011

Hard to Read?

Phone

0800 970 6115

for help
Til-ver.3s

Product Name Strength / Form Type Dimensions Typefaces Rev # Last updated No. of Colours

Lisinopril + Hydrochlorothiazide 20/12.5mg Tablets PIL 148 x 370 mm Font SansSerif Min. Text 8pt Till Ver.3s 02/02/11 Pantone Black CVC

Last modified: 03/11/08

Colour:
Pantone Black CVC

Regulatory: Approved: Signature:
QA:

Size:

148x360mm

Amendments Required: Date:

Task Allocated: Angela Information Provided by: Angela Prepared by: Shehzad PL No. Software: Adobe illustrator 9 (windows) Keyline: Yes
No Rog ver.1

Approved: Signature:

Amendments Required: Date:

General Sales & Marketing:

Tillomed Code: Pharma Code:

XXX XXX

Approved: Signature:

Amendments Required: Date:

Reason for changes : Tillomed Laboratories Ltd, 3 Howard Road Eaton Socon, St Neots, Cambs PE19 8ET, UK

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Advertisement
Close

Recommended

(web1)