Fosinopril and hydrochlorothiazide Doc Generici: detailed information

Patient Information Leaflet: Information for the User

FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics 20 mg + 12.5 mg Tablets

Generic Medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics is and what it is used for
What you need to know before taking FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics
How to take FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics
Possible side effects
How to store FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics
Contents of the pack and other information

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

The active substances in FOSINOPRIL and IDROCLOROTIAZIDE DOC Generici are fosinopril and hydrochlorothiazide.
Fosinopril belongs to a class of medicines called angiotensin-converting enzyme (ACE) inhibitors. ACE inhibitors work by dilating the blood vessels in the body, thereby reducing blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics. Diuretics help the body get rid of excess fluid and are used in patients with high blood pressure. Because diuretics increase the elimination of fluids, they are sometimes referred to as "water pills."
FOSINOPRIL and IDROCLOROTIAZIDE DOC Generici is used to treat high blood pressure (hypertension), when combination therapy with two active substances is considered appropriate.
This is usually the case when fosinopril alone does not provide adequate control of blood pressure.
FOSINOPRIL and IDROCLOROTIAZIDE DOC Generici may also be used to replace the combination of the two active substances (20 mg fosinopril and 12.5 mg hydrochlorothiazide) administered in the same proportions as two separate medicines.

2. What you should know before taking FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici

Do not take FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici

if you are allergic to sodium fosinopril, thiazides, sulfonamides, other ACE inhibitors, or any of the other ingredients of this medicine (listed in section 6)
if you have previously had swelling of the legs, arms, face, mucous membranes, or tongue and/or throat (angioedema), with or without treatment with ACE inhibitors
if there is a history of angioedema in your family
if you have severe kidney problems
if you have difficulty producing urine
if you have severe liver problems
if you are more than three months pregnant (It is best to avoid FOSINOPRIL and HYDROCHLOROTHIAZIDE 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
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat)

Warnings and precautions
Talk to your doctor or pharmacist before taking FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici.
Inform your doctor about any medical conditions you currently have or have had in the past:

if you have kidney problems, are on dialysis, or have had a kidney transplant
if you have been told that your heart muscle is enlarged or that you have heart valve problems
if you have liver disease
if you are receiving treatment to reduce your reactions to bee or wasp stings (desensitization) or undergoing so-called LDL apheresis
if you have immune system disorders due to certain diseases (e.g. scleroderma, systemic lupus erythematosus) or medicines (e.g. allopurinol, procainamide, lithium, steroids, or cancer treatments – see “Other medicines and FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici”)
if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion), increased pressure in the eye (glaucoma), or a sudden significant decrease in vision (acute myopia), which may occur from a few hours to several weeks after taking FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici. If left untreated, these conditions may lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this condition. If any of these symptoms occur, stop taking FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici and contact your doctor immediately, as medical treatment may be required.
if you experience swelling of the face, lips, tongue, and/or throat (angioedema)
if you are taking any of the following medicines, the risk of angioedema (rapid subcutaneous swelling, for example in the throat) may be increased:
Racecadotril, a medicine used to treat diarrhoea.
Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
Vildagliptin, a medicine used to treat diabetes.
if you experience severe abdominal pain making you feel unwell (intestinal angioedema)
if you are undergoing or about to undergo blood treatment to lower cholesterol using a machine (LDL apheresis)
if you have diabetes
if you have gout
if you have heart problems – narrowing of certain blood vessels in the brain or heart, or low blood volume
if you are dehydrated due to vomiting or diarrhoea, use of diuretics, potassium supplements, potassium-sparing medicines, potassium-containing salt substitutes, or a low-salt diet
if you develop a cough during treatment with this medicine
if you are taking any of the following medicines for high blood pressure:
an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes
aliskiren
if you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici
if you have had respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If, after taking FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici, you develop severe shortness of breath or difficulty breathing, consult a doctor immediately.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the section “Do not take FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici”.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici is not recommended in early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section Pregnancy).
Before undergoing any surgical or dental procedure, inform your doctor or dentist that you are being treated with FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici, as there is a risk of a sudden drop in blood pressure during anaesthesia.
For athletes
Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Ethnicity
This medicine may be less effective in lowering blood pressure in black patients compared to patients of other ethnicities.

Other medicines and FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici
Your treatment may be affected if FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici is taken together with certain other medicines. Inform your doctor before using any other medicines in combination with FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici. Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici with sacubitril/valsartan (a medicine used to treat heart failure) due to an increased risk of angioedema (rapid swelling under the skin, for example in the throat). See section “Do not take FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici”.
It is particularly important that your doctor knows if you are already being treated with any of the following medicines:

other medicines that lower blood pressure, including methyldopa, nitrates, beta-blockers, calcium antagonists, diuretics, or vasodilators, as they may further lower blood pressure
medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus and other mTOR inhibitors), racecadotril (a medicine used to treat diarrhoea), and vildagliptin (a medicine used to treat diabetes), due to increased risk of angioedema. See section “Warnings and precautions”.
potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting)
diuretics (water tablets) such as furosemide, spironolactone, triamterene, or amiloride, as these may further lower blood pressure or alter potassium or magnesium levels in the blood
painkillers and non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. aspirin or indomethacin), as they may reduce the effect of FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici or increase the side effects of aspirin. Concurrent use may lead to worsening of kidney function, especially if you are elderly or have kidney disease. Your doctor may consider periodic monitoring of kidney function
antacids containing magnesium or aluminium. These interfere with the absorption of FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici into the body; therefore, leave at least 2 hours between taking these antacids and FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici
calcium salts and vitamin D; concomitant use of FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici may cause an increase in calcium levels
insulin and oral diabetes medicines, as FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici may enhance the effect of these medicines, especially during the first week of combined treatment. Dose adjustment may be necessary
antidepressants (e.g. amitriptyline), barbiturates (e.g. phenobarbital), strong painkillers (e.g. morphine), and/or sedatives, as some of these medicines may enhance the blood pressure-lowering effect of FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici
lithium (used for bipolar disorder), as FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici may increase lithium levels in the blood
digoxin and digitoxin, as FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici may increase their side effects
medicines known as sympathomimetics, e.g. salbutamol, ephedrine, used to treat bronchitis and asthma, and some medicines used to treat cold, cough, or flu symptoms, as they may increase the blood pressure-lowering effect of FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici
adrenaline (epinephrine), as FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici may reduce its effect
ACTH (a hormone), carbenoxolone, amphotericin B, penicillin G, salicylates, or laxatives, as they may cause increased loss of potassium or magnesium from the body
allopurinol, procainamide, immunosuppressants (e.g. cyclosporine, azathioprine), steroids, or cancer medicines (e.g. cyclophosphamide, fluorouracil, or methotrexate), as they may affect certain blood cells. Additionally, the dose of some gout medications such as allopurinol and benzbromarone may need to be increased, as hydrochlorothiazide increases uric acid levels
cholestyramine or colestipol (used for high blood fat levels), as they may reduce the absorption of FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici
curare-like muscle relaxants (e.g. tubocurarine) administered during surgery, as FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici may increase the muscle-relaxing effect
certain antiarrhythmics, antipsychotics, and other medicines known to cause torsades de pointes (rapid, uncontrolled heartbeat) should not be taken concurrently with FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici
if you are taking ganglionic or peripheral adrenergic blockers
diazoxide, used to treat low blood sugar and high blood pressure
carbamazepine (a medicine for epilepsy), as concurrent use may lead to excessive reduction in blood sodium levels (hyponatremia)
results of certain laboratory tests such as digoxin assay (Kit RIA Digi-Tab), parathyroid tests, or protein-bound iodine (PBI) tests may be affected.

Antacids containing magnesium or aluminium (for heartburn) may reduce the effect of FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici. Therefore, wait at least two hours between taking FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici and antacids.
Your doctor may need to adjust your dose and/or take other precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also section “Do not take FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici” and “Warnings and precautions”).

FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici with food and alcohol
If you drink alcohol while taking FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici, you may experience dizziness/fainting, fatigue, or weakness, as the medicine may cause excessive lowering of blood pressure. A high-salt diet may reduce the effect of FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici is not recommended during pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious 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 start breast-feeding. FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici is not recommended for women who are breast-feeding, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby is a newborn or was born prematurely.

Driving and using machines
If you experience dizziness, fatigue, or vision problems, do not drive or operate machinery during treatment with FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici.

FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici contains lactose
FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici contains lactose (see section 6 for further information). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics

Swallow the tablets whole with at least half a glass of water in the morning, with or without food.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

For adults with high blood pressure, the recommended dose is one tablet once daily.
If you have kidney problems or are elderly, your dose may be adjusted.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.
Use in children
The use of FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics is not recommended in children and adolescents under 18 years of age.
If you take more FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics than you should
Contact your doctor, the nearest emergency department, or a poison control center immediately for advice.
If you forget to take FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics
Do not take the missed dose; instead, continue your treatment with the next dose as usual. Do not take a double dose to make up for the forgotten dose.
If you stop taking FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics
Do not stop taking FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics unless advised by your doctor. If you discontinue treatment with FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics, your blood pressure may increase.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects may occur:

Very common (may affect more than 1 in 10 people): High levels of sugar in the blood and urine, high levels of uric acid in the blood, electrolyte imbalance (including low levels of sodium and potassium in the blood), increased lipids in the blood (cholesterol and triglycerides).
Common (may affect up to 1 in 10 people): Upper respiratory tract infections (nose, throat), headache, dizziness, lightheadedness, weakness, fatigue, dry cough, skin inflammation, increased heart rate (tachycardia), awareness of heartbeat (palpitations), stomach irritation, constipation, reversible increase in substances normally eliminated in urine (creatinine, urea), muscle and bone pain.

If you experience dizziness/fainting, fatigue or weakness, especially when standing up (symptoms
of low blood pressure), contact your doctor as soon as possible.
If you develop swelling of the face, lips, tongue, and/or throat, or swelling of arms and legs,
rash, itching, shortness of breath or difficulty swallowing, stop taking FOSINOPRIL and
IDROCLOROTIAZIDE DOC Generici and contact your doctor immediately.

Uncommon (may affect up to 1 in 100 people): Taste disturbances, confusion, ear pain, loss of appetite, dry mouth, flatulence, runny nose, sinus inflammation, inflammation of trachea and bronchi (tracheobronchitis), breathing difficulties, fever, peripheral edema, sudden death, increased sweating, chest pain (not heart-related), weight gain, cardiac arrest, heart conduction disorders, reduced blood supply to tissues, transient reduction in blood supply to the brain, tremors, transient decrease in hemoglobin, reduced number of red blood cells, kidney inflammation, increased blood pressure, high levels of potassium in the blood, high levels of protein in the urine.

If you experience swelling of arms and legs, rash, itching, shortness of breath or difficulty
swallowing, stop taking FOSINOPRIL and IDROCLOROTIAZIDE DOC Generici and
contact your doctor immediately.

Rare (may affect up to 1 in 1,000 people): Skin reactions similar to systemic lupus erythematosus, reactivation of cutaneous lupus erythematosus, severe allergic reactions, serious skin reaction where the epidermis detaches in sheets and leaves large lesions (toxic epidermal necrolysis), nosebleeds, laryngitis, hoarseness, pneumonia, oral lesions, tongue swelling, difficulty swallowing, swollen salivary glands (sialadenitis), joint inflammation, memory disturbances, disorientation, language disorders, sleep disturbances, restlessness, stomach distension, prostate disorders, increase in certain types of white blood cells (eosinophilia), decreased production of blood cells, bleeding (hemorrhage), circulatory disorders in arms and legs (peripheral vascular disease), renal dysfunction, weakness of a limb, slight increase in hemoglobin levels in the blood, low levels of sodium in the blood.
If you experience any severe skin reaction, contact your doctor as soon as possible.
Very rare (may affect up to 1 in 10,000 people): Acute kidney failure, intestinal edema (intestinal angioedema), intestinal blockage (ileus), liver failure, acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).
Not known (frequency cannot be estimated from the available data): Sore throat, runny nose, anemia, changes in certain blood cells, abnormal enlargement of lymph nodes, gout, excessively high levels of alkali in blood and body fluids due to excessive chloride reduction, excessively high levels of alkali in blood and body tissues, depression, change in sexual desire, drowsiness, pins and needles sensation in the skin (paresthesia), reduced sense of touch (hypoesthesia), fainting, stroke, eye problems and vision disturbances such as "yellow vision" and blurred vision, decreased vision or eye pain due to increased pressure (possible signs of myopia, fluid accumulation in the vascular layer of the eye (choroidal effusion), or acute angle-closure glaucoma), tinnitus (ringing in the ears), vertigo, changes in heart rhythm, chest pain, heart attack, low blood pressure, drop in blood pressure upon standing (may cause dizziness or fainting), muscle pain during exercise that resolves with rest, hot flushes, inflammation of blood vessels, sinus congestion, lung inflammation, fluid in the lungs, contraction of the muscles lining the bronchi making breathing difficult, breathing difficulties, vomiting, diarrhea, stomach ache, nausea, indigestion, inflammation of the pancreas (pancreatitis), inflammation of the stomach and/or esophagus, taste disturbances, liver inflammation, yellowing of the skin and eyes (jaundice), rash, allergic reactions with swelling of the face, lips, tongue and/or throat or swelling of arms and legs (angioneurotic edema), hives, acute hypersensitivity reaction involving skin and mucous membranes (Stevens-Johnson syndrome), skin reaction characterized by red-blue spots (purpura), itching, light sensitivity, muscle pain, sudden and involuntary muscle contractions, joint pain, frequent urination, difficulty urinating, kidney failure, sexual dysfunction, edema, chest pain, muscle weakness, fever, abnormal clinical test results measuring liver function, altered levels of certain substances in the blood (blood electrolytes, uric acid, glucose, magnesium, cholesterol, triglycerides, calcium). A complex of symptoms has been reported which may include one or more of the following: fever, inflammation of blood vessels, muscle pain, joint pain/joint inflammation, positive test for antinuclear antibodies (ANA), increased erythrocyte sedimentation rate (ESR), increased number of certain types of white blood cells (eosinophilia), increased number of white blood cells in blood (leukocytosis), rash, light sensitivity or other skin manifestations, skin and lip cancer (non-melanoma skin cancer).

Stop taking FOSINOPRIL and IDROCLOROTIAZIDE DOC Generici and contact your doctor
immediately if you develop an infection with symptoms such as fever and worsening of your
general health condition or urinary problems. A blood test may be performed to check for a
possible reduction in white blood cells (agranulocytosis).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp." The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici contains

The active substances are sodium fosinopril and hydrochlorothiazide. One tablet contains 20 mg of sodium fosinopril and 12.5 mg of hydrochlorothiazide.
The other components are: monohydrate lactose, sodium croscarmellose, pregelatinized starch (maize), glycerol dibehenate, yellow iron oxide (E 172), red iron oxide (E 172) and titanium dioxide (E 171).

Description of the appearance of FOSINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici and pack contents
Light orange, round, flat, film-coated tablets with a diameter of 9 mm, marked “FH” on one side.
Each pack contains 10, 14, 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria