Document: leaflet MAH BRAND_PLPI 14251-0038 change
Package leaflet: Information for the patient
Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.
• Keep this leaflet. You may need to read it again
• If you have any further questions, please ask yourdoctor, pharmacist or nurse
• This medicine has been prescribed for you only. Do notpass it on to others. It may harm them, even if theirsigns of illness are the same as yours
• If you get any side effects, talk to your doctor, pharmacistor nurse. This includes any possible side effects not listedin this leaflet. See section 4.
In this leaflet
1. What Fosinopril Sodium Tablets are and what they areused for
2. What you need to know before you take FosinoprilSodium Tablets
3. How to take Fosinopril Sodium Tablets
4. Possible side effects
5. How to store Fosinopril Sodium Tablets
6. Contents of the pack and other information
1. What Fosinopril Sodium Tablets are and whatthey are used for
Each tablet contains the active ingredient fosinopril sodium which is used to treat high blood pressure (hypertension) andheart failure. Fosinopril Sodium Tablets belongs to a group ofmedicines called ACE inhibitors and make it easier for theheart to pump blood around the body.
2. What you need to know before you takeFosinopril Sodium Tablets
Do not take Fosinopril Sodium Tablets:
• if you are allergic (hypersensitive) to fosinopril sodium,other ACE inhibitors or any of the other ingredients of thismedicine (listed in section 6)
• if you or a member of your family have previously hadswelling of the legs, arms, face, mucous membranes ortongue and/or throat (angioedema), with or without ACEinhibitor treatment
• if you have narrowing of the blood vessels in one or bothkidneys
• if you are in shock due to heart problems (cardiogenicshock)
• if you are more than 3 months pregnant. (It is also better toavoid fosinopril sodium in early pregnancy - see‘Pregnancy and breast feeding' section)
if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicinecontaining aliskiren.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Fosinopril Sodium Tablets:
• if you have kidney problems
• if you have liver problems
• if you are having dialysis
• if you are going to undergo treatment for hypersensitivity tobee or wasp stings (hyposensitisation)
• if you have problems with your immune system due tosome diseases (eg scleroderma, lupus erythematosus),white blood cell counts will need to be monitored
• if you have high levels of sugar in your blood (diabetes)
• if you have narrowing of some blood vessels in the heartor cardiomyopathy (enlarged heart muscle)
• if you have become dehydrated from having recentlysuffered from vomiting or diarrhoea
• if you are on a low salt diet
• if you are Afro-Caribbean. If you are taking FosinoprilSodium Tablets as the only treatment for your high bloodpressure, you may have a reduced response to thismedicine. This may mean that you may need a higherdose than usually recommended
• if you think you are (or might become) pregnant.
Fosinopril sodium is not recommended in early pregnancy, and must not be taken if you are more than 3 monthspregnant, as they may cause serious harm to your baby ifused at that stage (see pregnancy section)
• if you are taking any of the following medicines used totreat high blood pressure:
• an angiotensin II receptor blocker (ARBs) (also known assartans - for example valsartan, telmesartan, 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 (eg potassium) in your bloodat 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 fosinoprilsodium, as there is a risk of your blood pressure sinking verylow during the anaesthetic.
Other medicines and Fosinopril Sodium Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 includingmethyldopa, betablockers (eg atenolol), calciumantagonists (eg verapamil) or diuretics (water tablets)
(eg furosemide) as it may lead to an increase in the blood pressure lowering effects
• potassium-sparing diuretics (eg spironolactone,triamterene or amiloride), potassium supplements orpotassium-containing salt substitutes, as fosinopril sodiummay increase potassium levels. Patients will need
their blood potassium levels measured by their doctor
• painkillers and anti-inflammatory medicines of theNSAID type (eg aspirin or indometacin) as they canreduce the effect of fosinopril sodium
• antacids (to relieve indigestion) stop the bodyabsorbing fosinopril sodium. There should be at least 2hours between taking the antacid and fosinopril sodium
• insulin and tablets used in diabetes, as fosinoprilsodium may increase the effect of these especially duringthe first week of combination treatment
• lithium (used for manic depression), as fosinopril sodiummay increase the concentration of lithium in the blood
• immunosuppressants (these reduce the body's naturaldefence system) such as azathioprine as using themtogether may affect some blood counts
• diuretic (water tablet) taken with fosinopril sodium maycause 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 'Donot take Fosinopril Sodium Tablets' and 'Warnings andprecautions').
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 tostop taking Fosinopril Sodium Tablets before you becomepregnant or as soon as you know you are pregnant and willadvise you to take another medicine instead of FosinoprilSodium Tablets. Fosinopril sodium is not recommended inearly pregnancy, and must not be taken when more than 3months pregnant, as it may cause serious harm to your babyif used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Fosinopril sodium is not recommended formothers who are breast-feeding, and your doctor maychoose 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 notdrive or use machinery during treatment with fosinoprilsodium.
Fosinopril Sodium Tablets contain lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine(see section 6 for further information).
Blood tests
Fosinopril sodium may interfere with the results of some blood tests. Tell your doctor that you are taking FosinoprilSodium Tablets.
(continued overleaf)
3. How to take Fosinopril Sodium Tablets
Always take Fosinopril Sodium Tablets exactly as your doctor or pharmacist has told you. Check with your doctor orpharmacist if you are not sure.
Swallow the tablets whole with at least / a glass of water in the morning with or without food. Do not chew or crush thetablets.
The recommended dose is 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 toreduce the dose of the diuretic or to stop taking them forseveral days before beginning treatment with fosinoprilsodium.
Occasionally some people start their treatment in hospital.
Use in children and adolescents under 18 years old.
Not recommended.
If you take more Fosinopril Sodium Tablets than you should:
Symptoms associated with overdose may include severe hypotension and renal failure. Immediately contact yourdoctor, the nearest hospital casualty department or the centrefor poison information for advice.
If you forget to take Fosinopril Sodium Tablets
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 aforgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you stop taking Fosinopril Sodium Tablets
Do not stop taking Fosinopril Sodium Tablets unless your doctor advises you to do so. If you stop taking fosinoprilsodium, your blood pressure may increase.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 ordifficulty swallowing (angioedema).
Tell your doctor if you notice any of the following side effects or they get worse:
• Common (may affect up to 1 in 10 people):infection of the upper respiratory tract (mouth, nose,throat or voice box), sore throat, runny nose, viralinfections, bacterial infection of the lungs(pneumonia), laryngitis (Inflammation of larynx (voicebox) lining and vocal cords), sinusitis (inflammation ofthe 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 onstanding up due to reduced blood pressure, low bloodpressure, 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 (causingswelling in the body), weakness or loss of strength
• Uncommon (may affect up to 1 in 100 people)fainting, shock
• Not known (frequency cannot be estimated from theavailable data): changes in types and number of bloodcells you may experience sore throat, recurring infections,nose bleeds, increased bruising), lack of appetite,appetite disorders, weight fluctuation, gout, raised levels ofpotassium in the blood, depression, abnormal behaviour,confusion, stroke, tremor, memory problems, problemswith balance, sleepiness or drowsiness, ear ache, tinnitus(ringing in the ear), vertigo ('spinning' sensation), heartattack, problems with heart rhythm or heart rate, flushing,high blood pressure or severe high blood pressure,bleeding, narrowing of the arteries in the legs, difficultybreathing or wheezing, congestion of the lungs, disorderof the voice (hoarse or weak voice), nosebleeds,inflammation of the sinuses, chest pain (not related to theheart), inflammation of the pancreas, swollen tongue,difficulty swallowing, constipation, dry mouth, flatulence,inflammation of the liver (causing yellowing of the skin oreyes or tiredness, pain in abdomen, joint or muscles),excessive sweating, bruising, itching, dermatitis (skinproblems/inflammation of the skin), skin rash that may beitchy (caused by an allergic reaction, pale or red irregularraised patches on the skin (hives)), weakness of themuscles, arthritis (pain and swelling of the joints), kidneyfailure, problems with sexual function, abnormality ordisease of the prostate gland, swelling of the soft tissue,fever with pain, increase in weight, abnormal liver functiontests, 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 effectsnot listed in this leaflet. You can also report side effectsdirectly via the Yellow Card Scheme atwww.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine
5. How to store Fosinopril Sodium Tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Keep in the original packaging. Keep the container tightly closed to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of thatmonth.
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 willhelp to protect the environment.
6. Contents of the pack and other information
What Fosinopril Sodium Tablets contain
• The active substance is fosinopril sodium. Each tabletcontains either 10mg or 20mg fosinopril sodium
• The other ingredients are lactose monohydrate,modified starch, croscarmellose sodium (E468),microcrystalline cellulose (E460), glycerol dibehenateand purified water.
• The sodium content is 0.67mg per 10mg tablet and1.06mg per 20mg tablet.
What Fosinopril Sodium Tablets look like and contents of the pack
Fosinopril Sodium Tablets are white to off white, round, flat, uncoated tablets.
The 10mg strength tablet is marked 'FL 10'. The 20mg strength tablet is marked 'FL 20'.
Each pack contains 30 tablets.
PL holder
Manx Healthcare Ltd, Taylor Group House,
Wedgnock Lane, Warwick, CV34 5YA
PL 14251/0037 Fosinopril Sodium 10mg Tablets PL 14251/0038 Fosinopril Sodium 20mg TabletsProcured from within the EUPOM
Manufacturer
Actavis hf, Reykjavikurvegur 78, IS-220 Hafnarfjordur, Iceland
To request a copy of this leaflet in large print, audio or Braille, please call 01926 482511.
This leaflet was last revised in September 2016
WIP URN: 200916-XXXX-PIL-02
