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Fosinopril Actavis

Document: Fosinopril Actavis tablet ENG PL change


PACKAGE LEAFLET


Package leaflet: Information for the user


Fosinopril Actavis 5 mg tablets

Fosinopril Actavis 10 mg tablets

Fosinopril Actavis 20 mg tablets


fosinopril sodium


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 further questions, please ask your doctor or your 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 Fosinopril Actavis is and what it is used for

2. What you need to know before you take Fosinopril Actavis

3. How to take Fosinopril Actavis

4. Possible side effects

5. How to store Fosinopril Actavis

6. Contents of the pack and other information


1. What Fosinopril Actavis is and what it is used for


Fosinopril Actavis belongs to a group of medicines called ACE inhibitors. Fosinopril Actavis lowers the blood pressure, and reduces the work-load of the heart in patients with heart failure.


Fosinopril Actavis is used in the treatment of

- high blood pressure

- heart failure (when the heart cannot pump enough blood around the body).


2. What you need to know before you take Fosinopril Actavis


Do not take Fosinopril Actavis:

- if you are allergic to fosinopril, other ACE inhibitors or any of the other ingredients of this medicine (listed in section 6).

- if you have previously had swollen legs, arms, face, mucous membranes or tongue (angioedema) in connection with use of ACE inhibitors or for some other, unknown reason, or if anyone in your family has had angioedema (this condition may be hereditary)

- if you are more than 3 months pregnant. (It is also better to avoid Fosinopril Actavis in early pregnancy – see pregnancy section.)

- 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 before taking Fosinopril Actavis:

- if you suffer from prolonged bouts of diarrhoea or vomiting, use potassium supplements, potassium-sparing medicines, potassium-containing salt substitutes or are on a low salt diet

- if you take diuretic medication (water tablets). Your doctor may discontinue diuretic therapy and correct volume and/or salt depletion before starting treatment with Fosinopril Actavis

- if you have a weak heart (heart failure) or heart disease (e.g. certain heart valve defects or thickening of the heart muscle)

- if you have low blood pressure

- if you have reduced kidney function, narrowing of the blood vessels to the kidneys, or liver disease. Your doctor may need to monitor you and change the dose of your medicine

- if you have diabetes. You may have to check your blood sugar more often in the first month of the treatment. See also “Other medicines and Fosinopril Actavis” below

- if you are undergoing treatment for hypersensitivity to bee or wasp stings (hyposensitisation treatment)

- if you are on haemodialysis. Tell your doctor so that a technique that does not cause hypersensitivity reactions can be chosen

- if you are having a procedure which removes bad cholesterol from your blood (LDL apheresis), you should not take Fosinopril Actavis. This is in order to avoid hypersensitivity reactions

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 Actavis”


At the start of the treatment and if you are taking other blood pressure reducing medicines at the same time, Fosinopril Actavis may cause symptoms of too low blood pressure (dizziness, fainting). Tell your doctor if these symptoms appear. Increasing the frequency of medical check-ups may be necessary in the beginning of treatment and/or during the period of dosage adjustment. You should not skip these visits even if you feel well. Your doctor will determine the frequency of control examinations.


Tell your doctor or dentist that you are being treated with Fosinopril Actavis before undergoing any anaesthetic for surgical or dental treatment, as there is a risk of your blood pressure becoming very low during the anaesthetic.


You must tell your doctor if you think you are (or might become) pregnant.

Fosinopril Actavis 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).


Other medicines and Fosinopril Actavis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.Some other medicines may affect or be affected by Fosinopril Actavis.

It is especially important for your doctor to know if you are already being treated with any of the following medicines:

- other medications that lower the blood pressure (other blood pressure lowering medicines, nitrates used in treatment of coronary artery disease, tricyclic antidepressants, phenothiazine used to treat psychoses, and barbiturates used to treat epilepsy)

- diuretics (water tablets)

- potassium sparing diuretics (e.g. amiloride, spironolactone and triamterene)

- potassium preparations (tablets or oral solutions)

- lithium (used to treat manic-depressive disease)

- NSAIDs such as acetylsalicylic acid, ibuprofen or ketoprofen on a regular basis and for long periods (NB: low doses of acetylsalicylic acid to prevent blood clots can be used safely with Fosinopril Actavis)

- sympathomimetic drugs (medicines that stimulate the central nervous system) which may also be found in some cough/cold remedies and asthma medication

- antidiabetic medicines (both insulin and oral products)

- allopurinol (used to treat gout), procainamide (used to treat irregular heart beat), medicines to treat cancer or medicines that inhibit your body’s immune system (immunosuppressants)


You should wait at least two hours between taking Fosinopril Actavis and antacids (a type of medicine used for heartburn and acid regurgitation).


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 Actavis” and “Warnings and precautions”).


Fosinopril Actavis with food and drink

Fosinopril Actavis should be taken with fluid (e.g. ½ a glass of water) and can be taken with or without food.

Alcohol can increase the blood pressure lowering effect of Fosinopril Actavis.


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 Fosinopril Actavis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Fosinopril Actavis. Fosinopril Actavis 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.When used in pregnancy, medicines like Fosinpril Actavis can cause injury and even death to the developing foetus.


Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Fosinopril Actavis 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

Some patients may experience dizziness (due to an excessive blood pressure lowering effect), which may affect the ability to drive and use machines. This occurs especially at the start of the treatment or when increasing the dose.


Fosinopril Actavis contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


3. How to take Fosinopril Actavis


Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.


High blood pressure:

The recommended starting dose is 10 mg daily. The dose may be increased to 40 mg daily if needed.


Heart failure:

The recommended starting dose is 10 mg daily. The dose may be increased to 40 mg daily if needed.


Patients with liver and kidney problems and elderly

The recommended starting dose is 10 mg daily.


Use in children and adolescents

Fosinopril Actavis is not recommended in children and adolescents under 18 years.


If you take more Fosinopril Actavis than you should

If you have taken more medicine than you should, or if children have been taking medicine by accident, please contact your doctor or hospital to get an opinion of the risk and advice on action to be taken.

Overdose can cause symptoms such as a fall in blood pressure with dizziness and fainting.


If you forget to take Fosinopril Actavis

Do not take a double dose to make up for a forgotten dose.


If you stop taking Fosinopril Actavis

Do not stop taking Fosinopril Actavis unless your doctor advises you to do so. If you stop taking Fosinopril Actavis, your blood pressure may increase and affect the function of your heart and kidneys.


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 Fosinopril Actavis and contact your doctor immediately

- if you get swelling of the face, lips, tongue and/or throat, rash, itching, shortness of breath or difficulty swallowing (angioedema) (common side effects)

- if you get an infection with symptoms such as fever with a much reduced general condition, or fever with sore throat or voiding problems (agranalocytosis) (very rare side effects).

- Yellowing of the skin and whites of eyes (jaundice) that may be signs of liver disease (very rare side effects).


Contact a doctor as soon as possible if you experience

- Dizziness/fainting, tiredness or weakness (signs of low blood pressure) (common side effects).

- If you have a dry cough which is persistent for a long time (common side effect).


Other side effects include:


Common(may affect up to 1 in 10 people):


Uncommon(may affect up to 1 in 100 people):


Rare(may affect up to 1 in 1,000 people):


Very rare(may affect up to 1 in 10,000 people):


Not known(frequency cannot be estimated from the available data):


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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Fosinopril Actavis


Keep this medicine out of the sight and reach of children.


Do not store above 25 °C.


Blister pack: Store in the original package in order to protect from moisture.

Tablet containers: Keep the container tightly closed in order to protect from moisture.


Do not use this medicine after the expiry date which is stated on the label, carton, and blister after EXP. The expiry date refers to the last day of that month.


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.


6. Contents of the pack and other information


What Fosinopril Actavis contains


- The active substance is fosinopril sodium. One tablet contains 5 mg, 10 mg or 20 mg fosinopril sodium.

- The other ingredients are lactose monohydrate, croscarmellose sodium, pregelatinised maize starch, microcrystalline cellulose and glycerol dibehenate.


What Fosinopril Actavis looks like and contents of the pack


Fosinopril Actavis 5 mg tablets are white to off-white, round tablets, marked “FL5” and 6 mm in diameter.

Fosinopril Actavis 10 mg tablets are white to off-white, round tablets, marked “FL10” and 8 mm in diameter.

Fosinopril Actavis 20 mg tablets are white to off-white, round tablets, marked “FL20” and 8 mm in diameter.


Pack sizes:

Blister packs: 10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets.

Plastic bottles: 50, 100, 250 and 500 tablets.


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer

[To be completed nationally]


For RMS:

Actavis Nordic A/S

Ørnegårdsvej 16

DK-2820 Gentofte

Denmark


Manufacturer

Actavis Nordic A/S

Ørnegårdsvej 16

DK-2820 Gentofte

Denmark


Actavis hf.

Reykjavíkurvegur 76-78

IS-220 Hafnarfjörður

Iceland


Genericon Pharma GmbH

Hafnerstrasse 211

A-8054 Graz

Austria


Balkanpharma Dupnitsa AD

3 Samokovsko Shose Str.

Dupnitsa 2600

Bulgaria


This medicinal product is authorised in the Member States of the EEA under the following names:


Estonia, Latvia, Sweden Fosinopril Actavis


Hungary Fosicard 5 mg, 10 mg, 20 mg tabletta


Lithuania Fosinopril Actavis 5 mg, 10 mg, 20 mg tabletés


Czech Republic Fosinopril + pharma 20 mg


Slovakia Fosinopril G.L. Pharma 20 mg


This leaflet was last revised in 2016-06-10