Fosinopril Sodium 20mg Tablets
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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 your pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet
J What Fosinopril sodium is and what it is used for
Before you take Fosinopril sodium tablets
^1 How to take Fosinopril sodium tablets
^ Possible side effects
How to store Fosinopril sodium tablets Further Information
J What Fosinopril sodium is and what it is used for
Each tablet contains fosinopril sodium which is used to treat high blood pressure (hypertension) and heart failure. Fosinopril sodium tablets belong to a group of medicines called ACE inhibitors and make it easier for the heart to pump blood around the body.
Before you take Fosinopril sodium tablets
Do not take Fosinopril sodium tablets and tell your doctor if you:
• are allergic (hypersensitive) to fosinopril sodium, other ACE inhibitors or any of the other ingredients in the tablet. (See Section 6 for further information on the ingredients)
• or a member of your family have previously had swelling of the legs, arms, face, mucous membranes or tongue and/or throat (angioedema), with or without ACE inhibitor treatment
• have narrowing of the blood vessels in one or both kidneys
• are in shock due to heart problems (cardiogenic shock)
• are more than 3 months pregnant. (It is also better to avoid fosinopril in early pregnancy - see 'Pregnancy and breast feeding' section.)
• have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Take special care with Fosinopril sodium tablets and tell your doctor if you:
• have kidney problems
• have liver problems
• are having dialysis
• are going to undergo treatment for hypersensitivity to bee or wasp stings (hyposensitisation)
• have problems with your immune system due to some diseases (e.g. scleroderma, lupus erythematosus), white blood cell counts will need to be monitored
• have high levels of sugar in your blood (diabetes)
• have narrowing of some blood vessels in the heart or cardiomyopathy (enlarged heart muscle)
• have become dehydrated from having recently suffered from vomiting or diarrhoea
• are on a low salt diet
• are Afro-Caribbean. If you are taking Fosinopril sodium tablets as the only treatment for your high blood pressure, you may have a reduced response to this medicine. This may mean that you may need a higher dose than usually recommended.
• think you are (or might become) pregnant. Fosinopril tablets are not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as they may cause serious harm to your baby if used at that stage (see pregnancy section).
• 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, telmesartan, irbesartan), in particular if you have diabetes-related kidney problems.
- Aliskerin
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 Fosinopril sodium tablets'
Tell your doctor or dentist before undergoing any surgery or dental treatment that you are being treated with Fosinopril, as there is a risk of your blood pressure sinking very low during the anaesthetic.
Taking other medicines
If Fosinopril is taken with certain other medicines, your treatment can be affected. Tell your doctor before using other medicines at the same time as Fosinopril. Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
It is especially important for your doctor to know if you are already being treated with any of the following medicines:
• other blood pressure lowering medicines including methyldopa, betablockers (e.g. atenolol), calcium antagonists (e.g. verapamil) or diuretics (water tablets) (e.g. furosemide) as it may lead to an increase in the blood pressure lowering effects
• potassium-sparing diuretics (e.g. spironolactone, triamterene or amiloride), potassium supplements or potassium-containing salt substitutes, as Fosinopril may increase potassium levels. Patients will need their blood potassium levels measured by their doctor
• painkillers and anti-inflammatory medicines of the NSAID type (e.g. aspirin or indometacin) as they can reduce the effect of Fosinopril
• antacids (to relieve indigestion) stop the body absorbing Fosinopril. There should be at least 2 hours between taking the antacid and Fosinopril
• insulin and tablets used in diabetes, as Fosinopril may increase the effect of these especially during the first week of combination treatment
• lithium (used for manic depression), as Fosinopril may increase the concentration of lithium in the blood
• immunosuppressants (these reduce the body's natural defence system) such as azathioprine
as using them together may affect some blood counts.
• diuretic (water tablet) taken with fosinopril may cause a reduction in blood pressure
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 Fosinopril sodium tablets' and 'Warnings and precautions')
Pregnancy and breastfeeding
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Fosinopril tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Fosinopril tablets. Fosinopril tablets are not recommended in early pregnancy,
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and must not be taken when more than 3 months pregnant, as they may cause serious harm to your baby if used after the third month of pregnancy.
Tell your doctor if you are breast-feeding or about to start breast-feeding. Fosinopril tablets are 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
If you experience dizziness, low blood pressure, light-headedness or vertigo ('spinning' sensation), do not drive or use machinery during treatment with Fosinopril.
Important information about some of the ingredients of Fosinopril
Fosinopril contains lactose (see section 6 for further information). If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Blood tests
Fosinopril may interfere with the results of some blood tests. Tell your doctor that you are taking Fosinopril sodium tablets.
How to take Fosinopril sodium tablets Swallow the tablets whole with at least ’A a glass of water in the morning with or without food.
Do not chew or crush the tablets.
Always take Fosinopril exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist
Adults: The usual dose is 10mg once daily, up to a maximum of 40mg once daily.
Fosinopril sodium tablets may be taken alone or in combination with a diuretic (water tablet) or digitalis (digoxin). If you are already taking diuretics, your doctor may tell you to reduce the dose of the diuretic or to stop taking them for several days before beginning treatment with Fosinopril. Occasionally some people start their treatment in hospital.
Children under 18 years old: Not recommended.
If you take more Fosinopril sodium than you should:
Immediately contact your doctor, the nearest hospital casualty department or the centre for poison information for advice.
If you forget to take Fosinopril sodium
Do not take the missed dose, just carry on with the next one as normal. Do not take a double dose to make up for a forgotten dose.
If you stop taking Fosinopril sodium
Do not stop taking Fosinopril unless your doctor advises you to do so. If you stop taking Fosinopril, your blood pressure may increase.
4 Possible side effects
Like all medicines, Fosinopril can cause side effects, although not everybody gets them. The following side effects may occur.
Stop taking Fosinopril sodium tablets and contact your doctor immediately if you
experience swelling of the face, lips, tongue and/ or throat, rash, itching, breathlessness or difficulty swallowing (angioedema).
Tell your doctor if you notice any of the following side effects or they get worse:
• Common (occurring in less than 1 in 10 patients): infection of the upper respiratory tract (mouth, noise, throat or voice box), sore throat, runny nose, viral infections, bacterial infection of the lungs (pneumonia), laryngitis (Inflammation of larynx (voice box) lining and vocal cords), sinusitis (inflammation of the sinus), inflammation of the trachea and the bronchi, altered moods, sleep disorders, dizziness, headaches, pins and needles, eye disorders or problems with sight, quick or irregular heart beat, chest pain, feeling faint on standing up due to reduced blood pressure, low blood pressure, cough, sinus disorder, feeling or being sick, diarrhoea, stomach pain, indigestion, taste disturbance, rash, pain in the muscles, tendons, ligaments and bone, problems urinating, fatigue, water retention (causing swelling in the body), weakness or loss of strength.
• Uncommon (occurring in less than 1 in 100 patients): fainting, shock
• Not known (cannot be estimated from the available data): changes in types and number of blood cells (you may experience sore throat, recurring infections, nose bleeds, increased bruising), lack of appetite, appetite disorders, weight fluctuation, gout, raised levels of potassium in the blood, depression, abnormal behaviour, confusion, stroke, tremor, memory problems, problems with balance, sleepiness or drowsiness, ear ache, tinnitus (ringing in the ear), vertigo ('spinning' sensation), heart attack, problems with heart rhythm or heart rate, flushing, high blood pressure or severe high blood pressure, bleeding, narrowing of the arteries in the legs, difficulty breathing or wheezing, congestion of the lungs, disorder of the voice (hoarse or weak voice), nosebleeds, inflammation of the sinuses, chest pain (not related to the heart), inflammation of the pancreas, swollen tongue, difficulty swallowing, constipation, dry mouth, flatulence, inflammation of the liver (causing yellowing of the skin or eyes or tiredness, pain in abdomen, joint or muscles), excessive sweating, bruising, itching, dermatitis (skin problems/inflammation of the skin), skin rash that may be itchy (caused by an allergic reaction, pale or red irregular raised patches on the skin (hives)), weakness of the muscles, arthritis (pain and swelling of the joints), kidney failure, problems with sexual function, abnormality or disease of the prostate gland, swelling of the
soft tissue, fever with pain, increase in weight, abnormal liver function tests, bloating of the stomach, mouth problems.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme 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 Fosinopril sodium tablets
Keep out of the reach and sight of children.
Do not store Fosinopril above 25°C.
Do not transfer to another container.
Do not use Fosinopril after the expiry date stated on the carton. 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 Fosinopril sodium tablets contain
• The active substance is fosinopril sodium. Each tablet contains either 10mg or 20mg of fosinopril sodium.
• The other ingredients are lactose monohydrate, croscarmellose sodium, pregelatinised starch (maize), microcrystalline cellulose, glycerol dibehenate and magnesium stearate.
• The sodium content is 0.67mg per 10mg tablets and 1.06mg per 20mg tablet.
What Fosinopril sodium tablets look like and contents of the pack
Fosinopril sodium tablets are white to off-white, round, uncoated tablets, which come in two strengths.
Each pack contains 28 tablets.
Marketing Authorisation Holder & Manufacturer:
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in: October 2014
If you would like a leaflet with larger % text, please contact 01271 311257.
actavis
Actavis, Barnstaple, EX32 8NS, UK
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