Lisinopril And Hydrochlorothiazide 10mg/12.5mg Tablets
Package Leaflet : Information for the user Lisinopril and Hydrochlorothiazide 10mg/12.5mg Tablets and
Lisinopril and Hydrochlorothiazide20mg/12.5mg Tablets Lisinopril and Hydrochlorothiazide Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1 What Lisinopril and Hydrochlorothiazide Tablets is and what it is used for
2 What you need to know before you take Lisinopril and Hydrochlorothiazide Tablets
3 How to take Lisinopril and Hydrochlorothiazide Tablets
4 Possible side effects
5 How to store Lisinopril and Hydrochlorothiazide Tablets
6 Contents of the pack and other information
1. What Lisinopril and Hydrochlorothiazide Tablets is and what it is used for
Lisinopril belongs to a group of medicines called ‘ACE Inhibitors'. These work by widening blood vessels which makes it easier for the heart to pump blood through them, to all parts of the body.
This helps to reduce blood pressure. Hydrochlorothiazide belongs to a group of medicines called water tablets. These work by increasing the amount of urine made by the kidneys. Each reduces blood pressure in a different way. These tablets are to treat high blood pressure.
2. What you need to know before you take Lisinopril and Hydrochlorothiazide Tablets
Do not take Lisinopril and Hydrochlorothiazide Tablets if you
• are allergic to lisinopril, hydrochlorothiazide or to certain water tablets, those similar to sulphonamides (a type of antibiotic) or any of the other ingredients of this medicine (listed in section 6).
• have been treated before with a medicine in the same group of drugs, ACE Inhibitors, and have had allergic reactions involving difficulty with swallowing or breathing, swelling of the hands, feet or ankles, face, lips, tongue or throat or if you or a member of your family has had a similar reaction for any other reason
• are more than 3 months pregnant. (It is also best to avoid Lisinopril and Hydrochlorothiazide Tablets in early pregnancy - see pregnancy section)
• are breast feeding or planning to breast feed
• have a narrowing of the aortic valve
• are not passing urine or have other kidney problems that your doctor does not know about
• are suffering from liver problems
• have high levels of potassium in your blood
• are under 18 years of age
• have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
If you think that any of these apply to you, do not take the tablets. Tell
your doctor and follow the advice given.
These tablets are only for you, they must not be given to anyone else.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lisinopril and Hydrochlorothiazide Tablets if you:
• have narrowing of the renal artery (renal artery stenosis) or an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy, HOCM)
• have any other heart problems e.g. angina
• have problems with liver or kidneys or are undergoing dialysis
• are on a low-salt diet and you use potassium containing salt substitutes or supplements
• suffer from diarrhoea or vomiting
• are going to have desensitisation treatment (e.g. treatment to reduce the effects of an allergy to bee or wasp stings)
• have diabetes, as you may need a different dose of your antidiabetic medicines
• have or have had the inflammatory condition known as lupus (systemic lupus erythematosus, SLE) which is caused by an autoimmune disease
• go into hospital tell the medical staff, especially the anaesthetist (if you are having an operation) that you are taking these tablets. You should also tell your dentist before you have an anaesthetic for a dental procedure
• must tell your doctor if you think you are (or might become) pregnant. Lisinopril and Hydrochlorothiazide Tablets 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).
• “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 Lisinopril and Hydrochlorothiazide Tablets”.
Check with your doctor, if you are not sure.
Other medicines and Lisinopril and Hydrochlorothiazide Tablets
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other 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 and Hydrochlorothiazide Tablets” and “Warnings and precautions”)”.
In particular tell your doctor or pharmacist if you are taking
• water tablets, as these may cause an excessive fall in your blood pressure
• other treatment for high blood pressure, as these may further reduce your blood pressure
• indomethacin (for arthritis or muscle pains), as this may reduce the effect of these tablets
• lithium (for depression), as taking these tablets may cause the level of lithium in your blood to rise
• drugs to treat depression, psychosis and anaesthetics as these
may further reduce your blood pressure
• sympathomimetics, drugs that affect a part of the nervous system that acts as a control system within your body, as they may reduce the blood pressure lowering effect of taking these tablets
• antidiabetics, as taking these tablets may increase chances of low blood sugar
• digitalis or digoxin preparations: Digitalis toxicity may be enhanced because of low potassium levels in the blood
• muscle relaxants, for example tubocurarine chloride, as their effects may be increased by these tablets
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 Lisinopril and Hydrochlorothiazide Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Lisinopril and Hydrochlorothiazide Tablets. Lisinopril and Hydrochlorothiazide Tablets is not recommended during 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. Lisinopril and Hydrochlorothiazide Tablets 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
When driving or using any tools or machines take care as these tablets may cause dizziness, low blood pressure and tiredness.
3. How to take Lisinopril and Hydrochlorothiazide Tablets Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. You must keep taking Lisinopril and Hydrochlorothiazide Tablets, even if you are feeling well, because regular treatment is most effective. The dose you take will depend on your condition and whether you are taking any other medicines.
• The usual dose is one or two tablets once a day, taken with a glass of water
• Try to take your tablet(s) at the same time each day. Many patients prefer to take them in the morning so that the effects of the water tablet (passing more water than usual) occur during the daytime
• If you are taking these tablets for the first time you may feel lightheaded or dizzy for a short time and it may help to sit or lie down. This is unlikely to happen when you are taking the tablets regularly. If you are worried, contact your doctor
If you take more Lisinopril and Hydrochlorothiazide Tablets than you should
If you take more than your normal dose, contact your doctor or nearest hospital.
If you forget to take Lisinopril and Hydrochlorothiazide Tablets
If you do forget to take a dose of your medicine at the correct time, just carry on with the next dose when it is due. Do not take a double dose to make up for a forgotten dose.
If you stop taking Lisinopril and Hydrochlorothiazide Tablets
Always check with your doctor before you stop taking this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Do not be alarmed by this list - you may not have any of them.
You should stop taking these tablets and contact your doctor immediately in any of the following situations: if you
• develop difficulty in breathing with or without swelling of the face, lips, tongue and/or throat
• develop swelling of the face, lips, tongue, and/or throat which may cause difficulty in swallowing
• develop severe itching of the skin (with raised lumps)
Lisinopril
Common: may affect up to 1 in 10 people
• dizziness
• headache
• low blood pressure which is felt on standing
• diarrhoea
• vomiting
• cough
• kidney problems
Uncommon: may affect up to 1 in 100 people
• mood alterations
• tingling or numbness in the hands or feet
• feeling of spinning sensation
• taste disturbance
• sleep disturbances
• heart attack
• rapid and irregular heartbeat
• poor blood circulation which makes the toes and fingers numb and pale
• running nose
• feeling sick
• abdominal pain and indigestion
• rash
• itching
• loss of sexual performance in man
• fatigue
• feeling weakness
• raised creatinine and urea blood levels, increases in liver enzymes, low blood levels of potassium
Rare: may affect up to 1 in 1,000 people
• low haemoglobin levels
• mental confusion
• dry mouth
• a serious allergic reaction with swelling of face, lips, tongue
• inflammation of mouth, and/or larynx
• hives
• hair loss
• reddening of the skin
• kidney failure
• breast enlargement in males
• high levels of bilirubin in the blood
• low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma
Very rare: may affect up to 1 in 10,000 people
• bone marrow depression
• reduction in red blood cells
• reduction in blood platelets which increases risk of bleeding or bruising
• severe reduction in number of white blood cells which makes infection more likely
• abnormal breakdown of red blood cells
• lymph disorders
• autoimmune disease
• low blood sugar levels
• shortness of breath
• swollen sinuses
• allergic lung disorder or accumulation of eosinophils in the lungs
• pancreas inflammation
• intestinal swellings
• jaundice due to impaired excretion of bile pigment
• profuse sweating
• a very rare but serious blistering of the skin
• rash involving reddening, swelling and peeling of the skin it resemble severe burns
• a severe and widespread reddening of the skin with blistering
• a painful reddening of the skin with lumps and blisters
With Hydrochlorothiazide few patients have reported the following
• loss of appetite
• stomach upsets
• nausea
• vomiting
• stomach cramps
• constipation
• jaundice seen as yellowing of the skin and/or whites of the eyes
• an inflamed pancreas marked by pain in the abdomen and back
• swelling of the salivary glands
• vertigo (spinning sensation)
• pins and needles
• headache
• visual changes which can make objects appear yellow
• anaemia marked by unusual tiredness and a loss of colour in the linings of the eyes and skin
• other blood disorders which can result in fever
• sore throat or prolonged bleeding after injury
• increased skin sensitivity to sunlight
• purplish or reddish-brown marks on the skin
• fever
• hives or a nettle-like rash
• inflammation of blood vessels
• breathing problems due to inflamed or swollen lungs
• allergic reactions marked by rash, hives, or difficulties in breathing or swallowing
• blistering or peeling of the skin, mouth, eyes or genitals
• changes in the levels of certain chemicals in the blood and urine which are usually detected by blood and urine tests
• kidney problems
• muscle spasm
• weakness
• restlessness
• blurred vision
It is possible that your doctor may occasionally take blood samples to check whether Lisinopril and Hydrochlorothiazide Tablets have had any effect on your blood for e.g. haemoglobin, blood count. Sometimes these changes may show themselves as tiredness or sore
throat, unusual bruising or bleeding.
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5 How to store Lisinopril and Hydrochlorothiazide Tablets
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. The expiry date refers to the last day of that month.
Store below 30°C. Store in the original carton to protect from light.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist howto throwaway medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Lisinopril and Hydrochlorothiazide Tablets contains
Lisinopril and Hydrochlorothiazide 10mg /12.5 mg Tablets contains lisinopril dihydrate equivalent to 10mg of lisinopril and 12.5mg of hydrochlorothiazide.
Lisinopril and Hydrochlorothiazide 20mg/12.5mg Tablets contains lisinopril dehydrate equivalent to 20mg of lisinopril and 12.5mg of hydrochlorothiazide.
The active substances are lisinopril dihydrate and hydrochlorothiazide. The other ingredients are mannitol (E 421), calcium hydrogen phosphate dihydrate, maize starch, pregelatinised starch, magnesium stearate.
Lisinopril and Hydrochlorothiazide 10mg/12.5mg Tablets also contain FD & C Blue No. 2 Aluminium Lake
Lisinopril and Hydrochlorothiazide 20mg/12.5mg Tablets also contain Yellow Iron Oxide
What Lisinopril and Hydrochlorothiazide Tablets look like and the contents of the pack
Lisinopril and Hydrochlorothiazide 10mg/12.5mg Tablets are blue, hexagonal tablets, without any markings
Lisinopril and Hydrochlorothiazide 20mg/12.5mg Tablets are yellow, hexagonal tablets, without any markings
Lisinopril and Hydrochlorothiazide Tablets are available in packs of 1,10, 14, 15, 20, 28, 30, 32, 40, 50, 56, 60, 70, 80, 84, 90, 98, 100, 200, 250, 400, 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited,
Victoria Court,
Bexton Road,
Knutsford,
Cheshire, WA16 0PF United Kingdom.
This leaflet was last revised in September 2014
Code No. GO/DRUGS/654 ID#: 239247