Fosinopril Sodium 20 Mg Tablets
TEVA UK Ref: 231-30-83880-X LEA FOSINOPRIL A/S TAB TUK Version: 1 16 June 2016
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Package leaflet: Information for the user
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.
as it may cause serious harm to your baby if used at that stage (see section 2: Pregnancy and breast-feeding).
Tell your doctor you are taking Fosinopril if you:
• have to go on a machine to remove cholesterol from the blood
• have to undergo desensitisation treatment (e.g. to reduce the effects of an allergy to wasp or bee stings)
• are to undergo a parathyroid test; tell your doctor you are taking Fosinopril, as you may be required to stop taking Fosinopril for a few days before the test
• are to have an operation requiring an anaesthetic (including treatment at the dentist); you should tell the doctor or dentist that you are taking Fosinopril.
If you get any side effects talk to your doctor or Other important information
pharmacist. This includes any possible side effects « not listed in this leaflet. See section 4.
What is in this leaflet
Pharma code 960
1. What Fosinopril is and what it is used for
2. What you need to know before you take Fosinopril
3. How to take Fosinopril
4. Possible side effects
5. How to store Fosinopril
6. Contents of the pack and other information
OWhat Fosinopril is and what it is used for
Fosinopril belongs to a group of drugs called Angiotensin Converting Enzyme (ACE) Inhibitors, which are vasodilators (drugs which widen the blood vessels, reduce blood pressure and make it easier for the heart to pump blood around the body).
Fosinopril is used to treat:
• high blood pressure
• congestive heart failure (a condition where the heart no longer pumps blood as effectively as it should).
0What you need to know before you take ' Fosinopril
Do not take Fosinopril and contact your doctor immediately:
• if you are allergic to fosinopril sodium, to any other angiotensin-converting enzyme (ACE) inhibitor or any of the other ingredients of this medicine (listed in section 6)
• if you have suffered an allergic reaction to any other ACE inhibitors e.g. captopril, enalapril, which led to swelling of the face, lips, tongue and/or throat
• if you have a condition known as hereditary
angioneurotic oedema, which is a serious allergic > reaction causing swelling of the face or throat, or have ever had a similar unexplained allergic reaction
• if you have the rare hereditary problem of
galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption • if you are more than 3 months pregnant. (It is also better to avoid Fosinopril in early pregnancy - see > section 2: Pregnancy and breast-feeding)
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
Warnings and precautions
Talk to your doctor or pharmacist before taking Fosinopril:
• if you have any of the following heart problems: narrowing of the heart valves, cardiomyopathy
Fosinopril may not work as well in Afro-Caribbean patients, and they may be at greater risk of certain side effects (see section 4, Possible side effects).
• Your doctor may monitor you when you first start taking Fosinopril. This may involve urine and blood tests.
Other medicines and Fosinopril
• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription: diuretics ("water tablets") e.g. amiloride, spironolactone, triamterene (see section 3, Taking in combination with a diuretic ("water tablet"))
other medicines for high blood pressure such as
methyldopa, beta-blockers e.g. propranolol, atenolol, sotalol, or calcium antagonists e.g. verapamil
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' and 'Warnings and precautions') potassium-containing salt substitutes, potassium supplements or heparin, as Fosinopril may increase potassium levels pain killers such as indometacin, ibuprofen or aspirin, as the effectiveness of Fosinopril may be reduced
antacids (to relieve indigestion), as the effectiveness of Fosinopril may be reduced. Doses of Fosinopril and antacids should be taken 2 hours apart
glyceryl trinitrate and other nitrates used to treat angina (chest pain).
vasodilators (drugs that cause blood vessels to expand) e.g. minoxidil procainamide (used to treat abnormal heart rhythms)
antidiabetics (insulin or oral hypoglycaemic drugs) e.g. tolbutamide
lithium, as lithium levels may be increased tricyclic antidepressants e.g. amitriptyline or dosulepin, or antipsychotics (used for psychiatric problems) e.g. flupenthixol immunosuppressants (drugs to reduce the body's natural defence system) e.g. cyclosporin, cytostatics, budesonide or procainamide systemic corticosteroids e.g. prednisone allopurinol (used to treat gout) medicines known as sympathomimetics e.g. salbutamol, ephedrine and some medicines for colds, coughs or flu symptoms which may contain these ingredients.
Fosinopril with food and drink
(inflammation of the heart muscle), ischaemic hearts DO NOT take alcohol whilst being treated with disease (lack of blood flow and oxygen to the heart) Fosinopril. if you have cerebrovascular disease (disease Pregnancy and breast-feeding affecting blo°d vessels in the brain) If you are pregnant or breast-feeding, think you may
if you have tadney problems mdiidmg disease of thebe pregnant or are planning to have a baby ask your a.rteries to the kidney or are undergoing dialysis doctor or pharmacist for advice before taking this
medicine.
• if you have collagen vascular disease e.g rheumatoid arthritis, SLE (systemic lupus erythematosus) an autoimmune condition which causes joint pain, skin rashes and fever
• if you have diabetes
• if you have low blood sodium
• if you have hypovolaemia (blood pressure falls due to fluid loss)
• if you have been on a low-salt diet
• if you have liver problems
• if you have become dehydrated e.g. you have recently suffered from severe diarrhoea or vomiting
• if you have a severe reduction in number of white blood cells which makes infections more likely.
• 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, 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 Fosinopril'.
• You must tell your doctor if you think you are (or might become) pregnant. Fosinopril is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant,
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Fosinopril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Fosinopril. Fosinopril 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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Fosinopril 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 and using machines:
• Fosinopril may cause dizziness and decreased blood pressure. If affected, DO NOT drive or operate machinery.
Fosinopril contains lactose
• Patients who are intolerant to lactose should note that Fosinopril tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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^3 How to take Fosinopril
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
In some cases, your treatment may be started in hospital so that you can be closely monitored.
The tablets should be swallowed preferably with a glass of water at the same time each day. The tablet should not be broken as it is available in several different strengths. The usual dose is:
Adults (including the elderly)
• High blood pressure
The recommended starting dose is 10 mg once daily. Your doctor may then alter the dose as necessary depending on your response to treatment, up to a maximum of 40 mg per day. Fosinopril may be taken alone or in combination with a diuretic ("water tablet', see below) to treat this condition.
• Heart failure
Fosinopril is usually taken in combination with a diuretic ("water tablet', see below), or with digitalis to treat this condition. The recommended starting dose is 10 mg once daily. Your doctor may then alter the dose as necessary depending on your response to treatment, up to a maximum of 40 mg per day.
• Taking in combination with a diuretic ("water tablet")
If you are already taking diuretics, your doctor may tell you to reduce the dose of the diuretic or to stop taking them for 2-3 days before beginning treatment with Fosinopril.
Children and adolescents (under 18 years old): Fosinopril is not recommended for use in children and adolescents under 18 years of age.
If you take more Fosinopril than you should If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
An overdose is likely to cause signs of faintness or dizziness due to a drop in blood pressure, weak pulse and clammy skin, hyperventilation, changes in heart rate or rhythm, anxiety, and cough.
Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Fosinopril
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.
If you stop taking Fosinopril DO NOT stop taking Fosinopril without talking to your doctor first even if you feel better. 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.
Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:
• allergic reactions which may include swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or nettle rash.
This is a very serious side effect. You may need urgent medical attention or hospitalisation.
The following side effects have been reported at the approximate frequencies shown:
Common (may affect up to 1 in 10 people):
• cough
• dizziness, weakness
• low blood pressure which may cause fainting or dizziness when standing up
• nausea, vomiting, diarrhoea
• rash, inflammation of the skin
• allergic reactions causing swelling of the face and throat (may be more common in Afro- Caribbean patients)
• headache
• fast heart rate or chest pain not related to the heart. Uncommon (may affect up to 1 in 100 people):
• excessive sweating, fever, runny or itchy nose, sinusitis, bronchitis (cough which may produce sputum), dry mouth
• itching, nettle rash
• shortness of breath and inflammation of the airways
• increased amounts of protein in the urine
• muscle pain and pain in the thorax or chest
• flatulence, constipation
• pins and needles
• depression, confusion
• sleepiness or sleep disturbances
• chest pain associated with the heart, palpitations or changes in heart rhythm
• swelling of hands and feet
• weight increase
• heart attack or stroke
• kidney problems
• decrease in red blood cells, high blood potassium levels
• decrease in appetite, taste changes
• fainting
• sexual problems
• gout
• problems with vision, ear ache, ringing in the ears, a sensation that your surroundings are spinning either up and down or from side to side
• high blood pressure
• collapse of the blood circulation with low blood pressure
• sudden death
• prostatic disorders in men.
Rare (may affect up to 1 in 1,000 people):
• hoarseness/laryngitis
• dysphasia (problems in the ability to select words in which to speak, read or write)
• inflammation of the pancreas
• difficulty in swallowing accompanied by swollen glands, swollen tongue or mouth sores
• weakness in limbs, arthritis
• blood disorders which may be characterised by fever or chills, sore throat, ulcers in your mouth or throat, low blood count causing unusual tiredness or weakness, unusual bleeding or unexplained bruising
• abdominal pain and swelling
• hepatitis - inflammation of the liver
• flushing of skin, bleeding problems, nose bleed
• peripheral vascular disease (disease of arteries)
• memory disturbances, disorientation
• pneumonia, congestion in the lungs
• difficulty in breathing
• low levels of salt in the blood
• raised levels of iron in the blood.
Vary rare (may affect up to 1 in 10,000 people):
• acute liver failure
• acute renal failure
• severe reduction in number of white blood cells making infections more likely
• inflammation and swelling of the bowel.
A disorder which may include fever, vasculitis (inflammation of blood vessels), muscle pain, joint pain/arthritis, blood disorders, rash, sensitivity to light or other skin problems has been reported. Fosinopril may interfere with the results of blood or urine tests.
Reporting of side effects
If you get any side effects, talk to your doctor or 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
Keep this medicine out of the sight and reach of children. Keep Fosinopril out of the reach and sight of children. Do not store above 25°C. Store in the original container. Do not transfer to another container. Do not use this medicine after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of that month.
Return all unused medicines to your pharmacist for safe disposal. 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 will help protect the environment.
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Contents of the pack and other information
What Fosinopril tablets contain:
• The active substance is fosinopril sodium, 10 mg or 20 mg.
• The other ingredients are lactose anhydrous, povidone K30, crospovidone, microcrystalline cellulose, sodium laurilsulfate, glycerol dibehenate.
What Fosinopril Tablets look like and contents of the pack
• Fosinopril 10mg Tablets are white to off-white in colour, round tablets scored on both sides of the tablet with "F" and "10" on each side of the score on one side of the tablet.
• Fosinopril 20mg Tablets are whiteto off-white capsule-shaped tablets with number embossed "93" on one side and "7223" on the other side.
The following pack sizes are available for:
• Fosinopril 10mg: 20, 28, 30, 50, 84, 90 or 100 tablets or 20 x 20 tablets as a hospital pack.
• Fosinopril 20mg: 14, 20, 28, 30, 50, 56, 84, 90 or 100 tablets or 20 x 20 tablets as a hospital pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG, England.
This leaflet was last revised: June 2016
PL 00289/0517-0518
83880-Y