Fosinopril Doc Generici

Package leaflet: Information for the patient

FOSINOPRIL DOC Generici 10 mg tablets, 20 mg tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 manage heart failure (impaired heart function).
Fosinopril sodium belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). It reduces the activity of certain enzymes. As a result, blood vessels relax, lowering blood pressure and improving heart function. To treat heart failure, FOSINOPRIL DOC Generici is given in combination with a diuretic (a medicine 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 sodium fosinopril or to other medicines of the same group (ACE inhibitors) or to any of the other ingredients of this medicine (listed in section 6);
• If, when taking a medicine of the same group (ACE inhibitor), you previously experienced sudden swelling of the face, lips, tongue or throat, causing difficulty in swallowing or breathing (angioedema), or if this type of reaction has occurred in you or a family member for any other reason;
• If you are more than three months pregnant. (You must avoid FOSINOPRIL DOC Generici even in the early stages of pregnancy – see section Pregnancy);
• If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine 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 enlarged or that you have stenosis (an abnormal narrowing of a blood vessel) of the aortic or mitral valve in the heart.
• Your kidney function is impaired.
• You are undergoing dialysis.
• Your liver function is impaired.
• You have diabetes (see also section “Using other medicines”).
• You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). FOSINOPRIL DOC Generici is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken during this period (see section Pregnancy).
• You are at increased risk of having high potassium levels in the blood. This may occur, for example, if your kidney function is impaired, if you have diabetes, or if you are taking a potassium-sparing diuretic (e.g. spironolactone), a potassium-containing salt substitute, or medicines that increase potassium levels, such as heparin.
• If you are taking lithium.
• If you are undergoing treatment to remove cholesterol from the blood (low-density lipoprotein or LDL apheresis using dextran sulfate).
• If you are undergoing desensitization treatment (a treatment that reduces your sensitivity to allergy effects or to bee or wasp stings).
• If you are prone to fainting or suffer from dizziness (low blood pressure).
• If you are undergoing surgery or general anesthesia, inform your doctor or dentist that you are taking fosinopril, as your blood pressure may drop during anesthesia.
• If you are being treated with any of the following medicines for high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the information under “Do not use FOSINOPRIL DOC Generici”.
Contact your doctor while taking fosinopril also if:

• You develop sudden fluid retention 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 must not use FOSINOPRIL DOC Generici.
• You develop fever, swollen glands, sore throat and mouth ulcers. These symptoms may indicate a low white blood cell count (neutropenia/agranulocytosis), which reduces your resistance. If you experience these symptoms, contact your doctor immediately. This warning particularly applies to patients with certain types of connective tissue disorders (collagenoses), patients treated with medicines that suppress the immune system (immunosuppressants), and

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

• If you have a persistent dry cough.
• If you are dehydrated (e.g. due to recent severe diarrhea or vomiting, use of diuretics, low-salt diet, or dialysis).
• If your skin or the whites of your eyes turn yellow (jaundice), which may indicate liver disease.

At the beginning of treatment, when the dose is increased, or when used concomitantly with other blood pressure-lowering medicines, 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may consider it necessary to adjust the dose and/or take additional 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”).
The following medicines are known to interact with FOSINOPRIL DOC Generici:

• Diuretics. Combining diuretics with FOSINOPRIL DOC Generici usually enhances the blood pressure-lowering effect of sodium fosinopril. Your doctor may decide to discontinue diuretics before starting treatment with FOSINOPRIL DOC Generici.
• Certain diuretics (potassium-sparing diuretics such as spironolactone, triamterene, and amiloride), and medicines containing potassium or increasing potassium levels. Combining these medicines with FOSINOPRIL DOC Generici may lead to increased potassium levels in the blood. This is particularly important if you have reduced kidney function, diabetes, or heart problems, as high potassium levels can be harmful to your heart;
• Lithium, a medicine used for severe depression. The use of FOSINOPRIL DOC Generici with lithium is not recommended, but if combination is necessary, lithium blood levels must be monitored regularly, as the risk of toxicity increases;
• Painkillers with anti-inflammatory and antipyretic activity (non-steroidal anti-inflammatory drugs (NSAIDs) such as indometacin, including acetylsalicylic acid at doses exceeding 3 grams per day). Concurrent use may reduce the blood pressure-lowering effect of FOSINOPRIL DOC Generici;
• Other medicines for high blood pressure. Concurrent use may enhance the blood pressure-lowering effect of FOSINOPRIL DOC Generici;
• Medicines for depression (tricyclic antidepressants), medicines for psychosis (antipsychotics), and anesthetics. Concurrent use/administration may further lower blood pressure;
• Medicines that stimulate certain parts of the nervous system (sympathomimetics). Concurrent use may reduce the blood pressure-lowering effect of FOSINOPRIL DOC Generici;
• Medicines used for diabetes (antidiabetics).
• Medicines that suppress the immune system or have a negative effect on white blood cell count (immunosuppressants, cytostatics, systemic corticosteroids, or procainamide, allopurinol).
• Alcohol. Concurrent use may enhance the blood pressure-lowering effect of FOSINOPRIL DOC Generici.
• Antacids (aluminum hydroxide, magnesium hydroxide, simethicone). Concurrent use may reduce the absorption of FOSINOPRIL DOC Generici. The two medicines should be administered at least 2 hours apart.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking FOSINOPRIL DOC Generici before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
FOSINOPRIL DOC Generici is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed.
FOSINOPRIL DOC Generici is not recommended for breast-feeding mothers, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby is newborn or was born prematurely.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breast-feeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
No studies have been conducted on the effects on the ability to drive and use machines.
A significant drop in blood pressure may in some cases cause dizziness as a side effect. If this occurs, you should take this into account when driving or operating machinery (especially dangerous equipment).
FOSINOPRIL DOC Generici contains lactose
This medicine contains lactose (milk sugar).
If you have been told that you have an intolerance to certain sugars, consult your doctor before starting this medicine.
For information on the ingredients, see section “6. Further information”, “What FOSINOPRIL DOC Generici contains”.

3. How to take FOSINOPRIL DOC Generici

Take this medicine exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
FOSINOPRIL DOC Generici should be administered orally as a single daily dose. As with all other medicines taken once daily, 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 starting dose is 10 mg once daily.
The recommended dose is 20 mg once daily.
Normal doses range between 10 mg and 40 mg, all taken once daily.

Treatment of heart failure
The recommended starting dose is 10 mg once daily.
Depending on the response, your doctor may gradually increase the dose to 40 mg once daily.

Patients with renal impairment or impaired liver function:
The recommended starting dose is 10 mg once daily.

Use in children and adolescents
Use in children and adolescents is not recommended.
Clinical experience with fosinopril in hypertensive children over 6 years of age is limited. In children of any age, the optimal dose has not been established. There is no suitable dosage form available for children weighing less than 50 kg.

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 include: shock due to inadequate blood circulation, disturbances in the body's electrolyte balance, kidney function disorders, hyperventilation, increased or decreased heart rate, palpitations, vertigo, anxiety, and cough.
If you suspect you have taken an excessive dose, contact a doctor immediately.

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

If you stop taking FOSINOPRIL DOC Generici
If you suddenly stop taking FOSINOPRIL DOC Generici, you will not experience any withdrawal symptoms. However, you will no longer benefit from its intended effects.
Always talk to your doctor if you are considering stopping treatment.

If you have any doubts about how to use this medicine, consult 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
• rapid heartbeat (tachycardia)
• low blood pressure (hypotension), drop in blood pressure when standing up too quickly from a sitting or lying position, sometimes accompanied by dizziness (orthostatic hypotension)
• cough
• nausea, vomiting, diarrhoea
• rash, sudden swelling of the face, lips, tongue or throat making swallowing or breathing difficult, 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

• transient decrease in haemoglobin, transient decrease in haematocrit
• decreased appetite, gout, excess potassium in the blood (hyperkalaemia)
• depression, confusion
• cerebral infarction, sensation of tingling, itching or prickling without apparent cause (paraesthesia), drowsiness, stroke, sudden loss of consciousness/tendency to faint (syncope), taste disturbances, tremor, sleep disorders
• impaired vision (visual disturbances)
• ear pain, ringing in the ears, dizziness
• painful sensation of tightness in the chest (angina pectoris), myocardial infarction (heart attack) or cerebrovascular accident, palpitations, cardiac arrest, heart rhythm disorders, disorders of cardiac conduction
• high blood pressure (hypertension), shock (inadequate blood flow to tissues, causing, among other things, pallor, restlessness, anxiety, yawning, low blood pressure and loss of consciousness), transient ischaemia
• shortness of breath, inflammation of the nasal mucous membranes (rhinitis), infection or inflammation of the sinuses (sinusitis), swelling or irritation of the trachea (tracheobronchitis)
• constipation, dry mouth, flatulence
• increased sweating, itching, blisters
• muscle pain (myalgia)
• renal failure, abnormal amount of protein in urine (proteinuria)
• sexual disorders
• fever, peripheral oedema, sudden death, chest pain
• weight gain, increased blood urea, increased serum creatinine, high level of potassium in blood

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

• transient anaemia, increase in certain types of white blood cells (eosinophilia), decrease in other types of white blood cells (leucopenia, neutropenia), lymph node disorders (lymphadenopathy), reduced number of platelets in the blood (thrombocytopenia)
• inability to use or understand language (dysphasia), memory problems, disorientation
• hot flushes, haemorrhages, peripheral vascular disorders
• difficulty breathing due to contraction of airway muscles (bronchospasm), nosebleeds, laryngitis/hoarseness, pneumonia, accumulation of blood in the lungs causing fluid retention in the lungs (pulmonary congestion)
• mouth lesions, 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
• inflammation of the liver (hepatitis)
• bruising
• inflammation of a joint (arthritis)
• prostate disorders
• weakness in one limb
• slight increase in haemoglobin, low sodium level in blood

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

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

Side effects with unknown frequency: frequency cannot be estimated from the available data
A set of symptoms including one or more of the following has been reported:

• fever, inflammation of blood vessels, muscle pain (myalgia), inflammation of a joint (arthralgia/arthritis), positive antinuclear antibodies (ANA), elevated erythrocyte sedimentation rate, increase in certain types of white blood cells (eosinophilia), and temporary increase in white blood cells (leucocytosis), skin rash, photosensitivity or other dermatological manifestations.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website
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 sight and reach of children.
Do not use this medicine after the expiry date stated on the box, on the bottle, and
on the blister pack after “EXP”.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original packaging to protect the medicine from moisture.
Bottle: Keep the bottle tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What FOSINOPRIL DOC Generici contains

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

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici Srl, Via Turati 40, 20121 Milano, Italy
Manufacturer:
Lamp San Prospero S.p.A., Via della Pace 25/A, 41030 S. Prospero (MO), Italy

This medicinal product is authorized in the European Economic Area Member States
under the following names:
Netherlands: Fosinoprilnatrium Apotex 10 mg; Fosinoprilnatrium Apotex 20 mg
Italy: FOSINOPRIL DOC Generici