tablet

PACKAGE LEAFLET

Fosinopril Medis 5 mg tablets
Fosinopril Medis 10 mg tablets
Fosinopril Medis 20 mg tablets

Fosinopril sodium

Read all of this leaflet carefully before you start using 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:
1. What Fosinopril Medis is and what it is used for
2. Before you take Fosinopril Medis
3. How to take Fosinopril Medis
4. Possible side effects
5. How to store Fosinopril Medis
6. Further information


1. WHAT FOSINOPRIL MEDIS IS AND WHAT IT IS USED FOR

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

Fosinopril Medis is used in the treatment of
- high blood pressure
- heart failure (when the heart cannot pump enough blood around the body).


2. BEFORE YOU TAKE FOSINOPRIL MEDIS

Do not take Fosinopril Medis:
- if you are allergic (hypersensitive) to fosinopril, other ACE inhibitors or any of the other
ingredients (see section 6 for further information on ingredients).
- 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 Medis in
early pregnancy – see pregnancy section.)

Take special care with Fosinopril Medis:
Consult your doctor before you start the treatment:
- 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
Medis
- 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 Taking other medicines 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 Medis. This is in order to avoid hypersensitivity
reactions.
- if you are taking lithium medicine used for the treatment of mania or depression.

At the start of the treatment and if you are taking other blood pressure reducing medicines at
the same time, Fosinopril Medis 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 Medis 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 Medis 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).


Taking other medicines
Some other medicines may affect or be affected by Fosinopril Medis. Please inform your
doctor or pharmacist if you are taking or have recently taken any other medicines, even those
not prescribed, as well as herbal remedies.
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 Medis)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 Medis and antacids (a type of
medicine used for heartburn and acid regurgitation).

Using Fosinopril Medis with food and drink
Fosinopril Medis 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 Medis.

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 Medis before you become
pregnant or as soon as you know you are pregnant and will advise you to take another
medicine instead of Fosinopril Medis. Fosinopril Medis 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 Medis can cause injury and even death to the developing foetus.

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

Important information about some of the ingredients of Fosinopril Medis:
This medicine 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 MEDIS

Always use Fosinopril Medis exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.

High blood pressure:
The usual starting dose is 10 mg daily. The dose may be increased to 40 mg daily if needed.

Heart failure:
The usual 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 usual starting dose is 10 mg daily.

Children and adolescents
Fosinopril Medis should is not recommended in children and adolescents < 18 years. There is
only limited information on the safety and effectiveness of Fosinopril Medis in children and
adolescents.

If you have the impression that the effect of Fosinopril Medis is too strong or too weak, talk to
your doctor or pharmacist.

If you take more Fosinopril Medis 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 Medis:
Do not take a double dose to make up for a forgotten dose.

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


4. POSSIBLE SIDE EFFECTS

Like all medicines, Fosinopril Medis can cause side effects, although not everybody gets
them.

Common side effects (affects 1 to 10 users in 100): upper respiratory tract infection, soar
throat, inflammation of the lining of the nose, viral infection, altered mood, sleep disorder,
dizziness, headache, pins and needles, alterations in taste, eye disorders, visual disturbances,
fast heart beat, heart rhythm disorders, chest pain from the heart (angina pectoris),
palpitations, too low blood pressure, a blood pressure drop when standing up quickly with
symptoms such as dizziness and fainting, cough, sinus disorder, nausea, vomiting, diarrhoea,
stomach pain, indigestion, skin rash, angioedema (swelling of the face, lips, tongue and/or
throat, see Stop taking Fosinopril Medis and contact a doctor immediately), skin
inflammation, pain in bones, muscles or joints, urination disorder, impotence, chest pain (not
from the heart), weakness, mental or physical tiredness, oedema, liver effects.

Uncommon side effects (affects 1 to 10 users in 1,000): alteration of blood values, increased
potassium levels, decreased appetite, gout, depression, confusion, heart attack, sudden
stopping of the heart beat, heart conduction disturbances, high blood pressure, shock, reduced
local blood circulation, sleepiness, stroke (cerebrovascular accident), fainting,, trembling,
earache, buzzing in the ears, spinning sensation, shortness of breath, constipation, mouth
dryness, flatulence, sweating, itching, urticaria, reduced kidney function, protein in the urine,
fever, swelling of arms and legs, chest pain, weight gain. Inflammation of the sinuses, lining
of the throat and windpipe.

Rare side effects (affects 1 to 10 users in 10,000): speech disturbances, memory disturbances,
disorientation, hot flashes, bleeding, blood vessel disease, temporary anaemia, enlarged lymph
glands, alterations in the number of platelets and some white cells in the blood, small
increases in haemoglobin, mouth ulcers, swollen tongue, difficulty swallowing, bruises,
bloating, joint pain, prostate problems, weakness in arms or legs, cramp in the windpipe,
nosebleed, decreased sodium levels, inflammation of the lungs, congestion of blood in the
lungs, inflammation of the pancreas and liver.

Very rare side effects (affects less than 1 user in 10 000): agranulocytosis (total lack of a
certain kind of blood cells, which increases the risk of infection, see Stop taking Fosinopril
Medis and contact a doctor immediately), swelling of blood vessels in the intestine (which is
experienced as abdominal pain, with or without nausea and vomiting), intestinal obstruction,
liver and kidney failure.

Not known (frequency cannot be estimated from the available data): appetite disorder, weight
fluctuation, abnormal behaviour, balance disorder, sudden stopping of the heart beat and
breathing, severe increase in blood pressure, impairment of the voice, chest pain (pleuritic
pain), muscular weakness, pain, abnormal liver function test.

Side effects in children and adolescents
The following side effects have been reported in children and adolescents:

Very common (affects more than 1 user in 10): headache.

Common (affects 1 to 10 users in 100): too low blood pressure, cough, increased potassium
levels, alteration of blood values.

Contact a doctor as soon as possible if you experience:
- dizziness/fainting, tiredness or weakness (signs of low blood pressure).
- If you have a dry cough which is persistent for a long time.

Stop taking Fosinopril Medis and contact your doctor immediately:
- if you get swelling of the face, lips, tongue and/or throat (angioedema), rash, itching,
shortness of breath or difficulty swallowing
- if you get an infection with symptoms such as fever with a much reduced general
condition, or fever with sore throat or voiding problems.
- Yellowing of the skin and whites of eyes (jaundice) that may be signs of liver disease.

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.


5. HOW TO STORE FOSINOPRIL MEDIS

- Keep out of the reach and sight of children.
- Do not store above 25 °C.
-
- Blister pack:
- Store in the original package in order to protect from moisture
- Tablet bottle:
- Unopened bottles. Do not use this medicine after the expiry date which is stated on the
package. The expiry date refers to the last day of that month.
- After opening: Keep the bottle tightly closed in order to protect from moisture. Use within
100 days after first opening the bottle.

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 Medis 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 Medis looks like and contents of the pack
Fosinopril Medis 5 mg tablets are white to off-white, round tablets, marked “FL5” and 6 mm
in diameter.
Fosinopril Medis 10 mg tablets are white to off-white, round tablets, marked “FL10” and 8
mm in diameter.
Fosinopril Medis 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
Actavis Group PTC ehf., Reykjavikurvegi 76-78, IS-220 Hafnarfjordur, Iceland

Manufacturer: Actavis hf., Reykjavikurvegur 78, IS-220 Hafnarfjordur, Iceland

This medicinal product is authorised in the Member States of the EEA under the
following names:
Austria Fosinopril Actavis 10 mg Tabletten
Fosinopril Actavis 20 mg Tabletten
Iceland Fosinopril Actavis
Italy Fosimed
Malta Fosinopril Actavis
Poland Fosinopril Actavis
Slovenia Fosicard 5 mg tablete
Fosicard 10 mg tablete
Fosicard 20 mg tablete
Spain Fosinopril Actavis 5 mg comprimidos
Fosinopril Actavis 10 mg comprimidos EFG
Fosinopril Actavis 20 mg comprimidos EFG
Sweden Fosinopril Medis

This leaflet was last approved in 2012-05-02