FOSINOPRIL 10 мг Таблетка

Содержание инструкции

1. FOSINOPRIL DOC Generici 10 mg tablets, 20 mg tablets
   1. What FOSINOPRIL DOC Generici is and what it is used for
   2. What you need to know before taking FOSINOPRIL DOC Generici
   3. How to take FOSINOPRIL DOC Generici
2. FOSINOPRIL DOC Generici must be administered orally in a single dose
   1. Possible side effects
   2. How to store FOSINOPRIL DOC Generici
   3. Contents of the pack and other information

FOSINOPRIL DOC Generici 10 mg tablets, 20 mg tablets

Equivalent Medicinal Product
Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What FOSINOPRIL DOC Generici is and what it is used for
• 2. What you need to know before you take FOSINOPRIL DOC Generici
• 3. How to take FOSINOPRIL DOC Generici
• 4. Possible side effects
• 5. How to store FOSINOPRIL DOC Generici
• 6. Contents of the pack and other information

1. What FOSINOPRIL DOC Generici is and what it is used for

FOSINOPRIL DOC Generici tablets are used to treat high blood pressure and to treat
heart failure (impaired cardiac function).
Fosinopril sodium belongs to a group of medicines called ACE inhibitors (angiotensin converting
enzyme inhibitors). It reduces the rate at which certain enzymes work. The result is a
relaxation of the blood vessels, which reduces blood pressure and improves the way the
heart works. To treat heart failure, FOSINOPRIL DOC Generici is given in association with a
diuretic (a drug that increases urine production).

2. What you need to know before taking FOSINOPRIL DOC Generici

Do not use FOSINOPRIL DOC Generici

• If you are allergic to fosinopril sodium or other medicines of the same group (ACE inhibitors) or to any of the other ingredients of this medicine (listed in section 6);
• If, while using a medicine of the same group (ACE inhibitor) you have previously experienced a sudden swelling of the face, lips, tongue or throat, which made it difficult to swallow or breathe (angioedema) or if this type of reaction has occurred to you or a family member for any other reason;
• If you are pregnant for more than three months. (You should also avoid FOSINOPRIL DOC Generici in the early stages of pregnancy - see the Pregnancy section);
• If you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Warnings and precautions
Consult your doctor if you are or have recently been in any of the following situations:

• You have been told that your heart muscle is thickened or that you have a stenosis (an abnormal narrowing of a blood vessel) of the aortic valve or mitral valve in the heart.
• Your kidney function is impaired.
• You are undergoing dialysis.
• Your liver function is impaired.
• You are diabetic (see also the section “Using other medicines”).
• You must inform your doctor if you think you may be pregnant (or if there is a possibility of starting a pregnancy). FOSINOPRIL DOC Generici is not recommended in early pregnancy, and should not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken during this period (see the Pregnancy section).
• You are at higher risk of having too high levels of potassium in your blood. This can happen, for example, if your kidney function is impaired, if you have diabetes or if you are using a potassium-sparing diuretic (e.g. spironolactone), a potassium-based salt substitute or medicines that increase potassium levels, such as heparin.
• If you are using lithium.
• If you are being treated to remove cholesterol from the blood (low-density lipoprotein or LDL apheresis using dextran sulfate).
• If you are going to undergo desensitization treatment (a treatment that makes you less sensitive to the effects of an allergy or to bee or wasp stings).
• If you are prone to fainting or suffer from dizziness (low blood pressure).
• If you are going to undergo surgery or general anesthesia, tell your doctor or dentist that you are taking fosinopril, as blood pressure may drop during anesthesia.
• If you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren.

The doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated under “Do not use FOSINOPRIL DOC Generici”.
When using fosinopril, also contact your doctor if:

• You experience a sudden retention of fluid in the skin and mucous membranes (e.g. throat or tongue), shortness of breath and/or itching and skin rashes, often due to an allergic reaction (angioedema). See also the section on when you cannot use FOSINOPRIL DOC Generici.
• You develop a fever, swollen glands, sore throat and ulcers in the mouth. These symptoms may indicate a shortage of white blood cells (neutropenia/agranulocytosis), which reduces your resistance. If you experience these symptoms, contact your doctor immediately. This warning applies particularly to patients with certain types of connective tissue disorders (collagenoses), patients treated with medicines that suppress the immune system (immunosuppressants) and

patients who use allopurinol or procainamide, especially if they have impaired kidney
function.

• If you have a dry, persistent cough.
• If you suffer from dehydration (e.g. in the case of recent severe diarrhea or vomiting, use of diuretics, a low-salt diet or dialysis).
• If your skin or the whites of your eyes become yellow (jaundice), which may indicate a liver disease.

At the beginning of treatment, when the dose is increased and in case of concomitant use
with other medicines that lower blood pressure, FOSINOPRIL DOC Generici may cause
symptoms of low blood pressure (dizziness, fainting). If these symptoms occur, always
consult your doctor.

Other medicines and FOSINOPRIL DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
The doctor may need to adjust the dose and/or take other precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren
(see also “Do not use FOSINOPRIL DOC Generici” and
“Warnings and precautions”).
We know that the following medicines interact with FOSINOPRIL DOC Generici:

• diuretics. The combination of diuretics and FOSINOPRIL DOC Generici usually increases the effect of fosinopril sodium in lowering blood pressure. The doctor may decide to stop the diuretics before starting treatment with FOSINOPRIL DOC Generici.
• Some diuretics (potassium-sparing diuretics such as spironolactone, triamterene and amiloride) and medicines containing potassium or that increase potassium levels. The combination of these medicines with FOSINOPRIL DOC Generici can lead to an increase in potassium levels in the blood. This is particularly important if you have reduced kidney function, diabetes or heart problems, because too high levels of potassium are harmful to your heart;
• Lithium, a medicine used for severe depression. The use of FOSINOPRIL DOC Generici with lithium is not recommended, but if the combination is necessary, lithium levels in the blood must be checked regularly because it increases the risk of toxicity.
• pain relievers with anti-inflammatory and antipyretic activity (non-steroidal anti-inflammatory drugs (NSAIDs) such as indometacin, including acetylsalicylic acid at doses higher than 3 grams per day). Concurrent use may decrease the activity of FOSINOPRIL DOC Generici in lowering blood pressure;
• other medicines against high blood pressure. Concurrent use may increase the activity of FOSINOPRIL DOC Generici in lowering blood pressure;
• medicines against depression (tricyclic antidepressants), medicines against psychosis (antipsychotics) and anesthetics. Concurrent use/administration may further reduce blood pressure;
• medicines capable of stimulating certain parts of the nervous system (sympathomimetics). Concurrent use may decrease the activity of FOSINOPRIL DOC Generici in lowering blood pressure;
• medicines used for diabetes (antidiabetics).
• Medicines that suppress the immune system or have a negative effect on the number of white blood cells (immunosuppressants, cytostatics, systemic corticosteroids or procainamide, allopurinol).
• Alcohol. Concurrent use may increase the activity of FOSINOPRIL DOC Generici in lowering blood pressure
• Antacids (aluminum hydroxide, magnesium hydroxide, simethicone). Concurrent use may decrease the absorption of FOSINOPRIL DOC Generici. The administration of the two medicines should be spaced at least 2 hours apart.

Pregnancy and breastfeeding

Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). As a rule, your doctor will advise you to stop
taking FOSINOPRIL DOC Generici before starting pregnancy or as soon as you
find out you are pregnant and will advise you to take another
medicine instead of FOSINOPRIL DOC Generici.
FOSINOPRIL DOC Generici is not recommended in early pregnancy, and should not
be taken if you are pregnant for more than three months, as it can cause serious
harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are going to start breastfeeding.
FOSINOPRIL DOC Generici is not recommended for mothers who are breastfeeding and
the doctor may choose another treatment if you wish to breastfeed, especially if your
baby is newly born or premature.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.

Driving and operating machinery
Studies on the effects on the ability to drive and operate machinery have not been conducted.
A sharp drop in blood pressure can in some cases cause dizziness as a side
effect. If this happens to you, you must take this into account when driving or operating dangerous
equipment.

FOSINOPRIL DOC Generici contains lactose
This medicine contains lactose (milk sugar).
If you have been told that you have an intolerance to some sugars, contact your doctor before
starting to take this medicine.
For information on the ingredients, see “6. Further information”, “What contains
FOSINOPRIL DOC Generici”.

3. How to take FOSINOPRIL DOC Generici

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.

FOSINOPRIL DOC Generici must be administered orally in a single dose

daily. As with all other medications taken once a day, it should be taken
approximately at the same time each day.
The best way to take the tablets is with plenty of water (half a glass), with or
without food.

High blood pressure
The recommended initial dose is 10 mg once a day.
The recommended dose is 20mg once a day.
Normal doses are those between 10 mg and 40 mg, all taken once a day.

Treatment of heart failure
The recommended initial dose is 10 mg once a day.
Depending on the effect, the doctor may gradually increase the dose to 40 mg once a
day.

Patients with renal insufficiency or impaired liver function:
The recommended initial dose is 10 mg once a day.

Use in children and adolescents
Use in children and adolescents is not recommended.
The experience of clinical studies on the use of fosinopril in hypertensive children over 6 years of age is
limited. In children of any age, the optimal dose has not been determined. A dose suitable for children weighing less than 50 kg is not
available.

If you take more FOSINOPRIL DOC Generici than you should
If you have taken too much FOSINOPRIL DOC Generici, the following symptoms may occur:
dizziness and fainting due to very low blood pressure. Other possible effects are: shock
as a result of insufficient blood circulation, disorders in the body's salt balance
renal dysfunction, hyperventilation, increased or decreased heart rate,
palpitations, dizziness, anxiety and cough.
If you suspect you have taken an overdose, contact a doctor immediately.

If you forget to take FOSINOPRIL DOC Generici
If you have forgotten to take a dose, do nothing. Take the next dose
at the usual time. Do not take a double dose to make up for forgetting the tablet.

If you stop taking FOSINOPRIL DOC Generici
If you suddenly stop taking FOSINOPRIL DOC Generici, you will not have any
withdrawal symptoms. However, you will no longer have the desired effects.
Always talk to your doctor if you are thinking of stopping.
If you have any questions about 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.
The following side effects have been reported:

Common side effects: may affect up to 1 in 10 people

• dizziness, headache
• fast heartbeat (tachycardia)
• low blood pressure (hypotension), drop in blood pressure when getting up too quickly from a sitting or lying position, sometimes accompanied by dizziness (orthostatic hypotension)
• cough
• nausea, vomiting, diarrhea
• skin rash, sudden swelling of the face, lips, tongue or throat that makes it difficult to swallow or breathe, often as a result of an allergic reaction (angioedema), skin inflammation (dermatitis)
• chest pain (non-cardiac), weakness
• increased alkaline phosphatase, increased bilirubin, increased LDH, increased transaminases

Uncommon side effects: may affect up to 1 in 100 people

• temporary decrease in hemoglobin, temporary decrease in hematocrit
• decreased appetite, gout, excess potassium in the blood (hyperkalemia)
• depression, confusion
• stroke, tingling, itching or pins and needles sensation without apparent cause (paresthesia), drowsiness, stroke, sudden loss of consciousness/tendency to faint (syncope), taste disturbances, tremor, sleep disorders
• impaired vision (visual disturbances)
• earache, ringing in the ears, vertigo
• painful chest tightness (angina pectoris), myocardial infarction (heart attack) or stroke, palpitations, cardiac arrest, heart rhythm disorders, cardiac conduction disorders
• high blood pressure (hypertension), shock (insufficient blood flow to the tissues, which causes, among other things, pallor, agitation, anxiety, yawning, low blood pressure and loss of consciousness), transient ischemia
• shortness of breath, inflammation of the nasal mucous membranes (rhinitis), sinus infection or inflammation (sinusitis), swelling or irritation of the trachea (tracheobronchitis)
• constipation, dry mouth, flatulence
• increased sweating, itching, blisters
• muscle pain (myalgia)
• kidney failure, abnormal amount of protein in the urine (proteinuria)
• sexual dysfunction
• fever, peripheral edema, sudden death, chest pain
• weight gain, increased urea in the blood, increased creatinine in the serum, elevated potassium level in the blood

Rare side effects: may affect up to 1 in 1,000 people

• temporary anemia, increase in some types of white blood cells (eosinophilia), decrease in other types of white blood cells (leukopenia, neutropenia), lymph node disorders (lymphadenopathy), decreased number of platelets in the blood (thrombocytopenia)
• inability to use or understand language (dysphasia), memory problems, disorientation
• hot flashes, bleeding, peripheral vascular disorders
• difficulty breathing due to contraction of the muscles of the airways (bronchospasm), nosebleeds, laryngitis/hoarseness, pneumonia, accumulation of blood in the lungs causing fluid retention in the lungs (pulmonary congestion)
• lesions in the mouth, inflammation of the pancreas with severe pain in the upper abdomen radiating to the back with nausea and vomiting (pancreatitis), swelling of the tongue, abdominal swelling, difficulty swallowing
• liver inflammation (hepatitis)
• bruising
• inflammation of a joint (arthritis)
• prostate disorders
• weakness in a limb
• mild increase in hemoglobin, low sodium level in the blood

Very rare side effects: may affect up to 1 in 10,000 people

• decrease in the number of white blood cells (agranulocytosis)
• stomach pain with or without nausea and vomiting (intestinal angioedema), intestinal obstruction ((sub) ileus)
• acute kidney failure
• liver failure

Side effects with unknown frequency: the frequency cannot be estimated based on
available data
A set of symptoms has been reported that includes one or more of the following:

• fever, inflammation of blood vessels, muscle pain (myalgia), inflammation of a joint (arthralgia/arthritis), positive antinuclear antibodies (ANA), increased erythrocyte sedimentation rate, increase in some types of white blood cells (eosinophilia) and temporary increase in white blood cells (leukocytosis), skin rash, sensitivity to light or other dermatological manifestations.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store FOSINOPRIL DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
pack, bottle and blister after “EXP”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25ºC.
Store in the original packaging to protect the medicine from moisture.

Bottle:Keep the bottle tightly closed.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FOSINOPRIL DOC Generici contains

• The active ingredient is fosinopril sodium. Each tablet contains 10 mg or 20 mg of fosinopril sodium.
• The other ingredients are anhydrous lactose, crospovidone type A (E1202) and zinc stearate.

Description of the appearance of FOSINOPRIL DOC Generici and contents of the pack
The 10mg tablets are white and capsule-shaped with incisions. On one side they are
imprinted with the letters “APO” and on the other side “FOS-10”.
The 20mg tablets are white and oval-shaped. On one side they are imprinted with the letters
“APO” and on the other side “FOS-20”.
This medicine is available in blisters and bottles.
The tablets are available in blister packs of 4, 14, 20, 21, 28, 30, 50, 56, 60, 100
and 400 tablets and in bottles of 30, 60, 100 and 400 tablets.
Not all pack sizes may be marketed.
Note: each bottle contains a small desiccant (to keep
the tablets dry). Do not ingest this desiccant!

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
DOC Generici Srl, Via Turati 40, 20121 Milano

Manufacturer:
Lamp San Prospero S.p.A., Via della Pace 25/A, 41030 S Prospero (MO)

This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:
Netherlands Fosinoprilnatrium Apotex 10 mg; Fosinoprilnatrium Apotex 20 mg
Italy FOSINOPRIL DOC Generici