Fosinopril and hydrochlorothiazide Mylan Generics: detailed information

Patient Information Leaflet

Fosinopril and Hydrochlorothiazide Mylan Generics 20 mg/12.5 mg tablets

fosinopril sodium/hydrochlorothiazide
Generic medicine
Please 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 any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may 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

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

1. What Fosinopril and Hydrochlorothiazide Mylan Generics is and what it is used for

The active substances in Fosinopril and Hydrochlorothiazide Mylan Generics 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, which can reduce 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 they remove fluid, diuretics are often called water tablets.
Fosinopril and Hydrochlorothiazide Mylan Generics is used to treat high blood pressure (hypertension), when treatment with a combination of two active substances is considered appropriate. This is usually the case when fosinopril alone does not provide adequate blood pressure control.
Fosinopril and Hydrochlorothiazide Mylan Generics may also be used to replace the combination of the two active substances (20 mg of fosinopril and 12.5 mg of hydrochlorothiazide) given in the same proportions as two separate medicines.

2. What you need to know before taking Fosinopril and Hydrochlorothiazide Mylan Generics

Do not take Fosinopril and Hydrochlorothiazide Mylan Generics 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).
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.
you have a history of angioedema in your family.
you have severe kidney problems.
you have difficulty producing urine.
you have severe liver problems.
you are more than three months pregnant (see section "Pregnancy and breastfeeding").
you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
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 Mylan Generics.
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.
you have been told you have thickened heart muscle or heart valve problems.
you have liver disease.
you are receiving treatment to reduce your reactions to bee or wasp stings (desensitization).
you have immune system problems 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 Mylan Generics").
you experience swelling of the face, lips, tongue, and/or throat (angioedema).
you experience severe abdominal pain causing general malaise (intestinal angioedema).
you have undergone or are scheduled to undergo treatment with a machine that lowers cholesterol levels in the blood (LDL apheresis).
you have diabetes.
you have gout.
you have heart problems – narrowing of certain blood vessels in the brain or heart, or low blood volume.
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.
you develop a cough during treatment with this medicine.
you are taking any of the following medicines used to treat 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.
you are taking any of the following medicines, which may increase the risk of angioedema:
- 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.
you have previously had skin cancer or develop an unexpected skin lesion 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 exposure to sunlight and UV rays during treatment with Fosinopril and Hydrochlorothiazide Mylan Generics.
If you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure inside the eye and may occur from a few hours to weeks after taking Fosinopril and Hydrochlorothiazide Mylan Generics. If untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.

You must inform your doctor if you think you are pregnant (or if there is any possibility of becoming pregnant). Fosinopril and Hydrochlorothiazide Mylan Generics is not recommended during 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 treatment, inform your doctor or dentist that you are taking Fosinopril and Hydrochlorothiazide Mylan Generics, as there is a risk of a sudden drop in blood pressure during anaesthesia.
Anti-doping tests
Caution for athletes: this product contains substances prohibited in doping. It is forbidden to take this medicine in a dosage regimen or by a route of administration different from those indicated.
If you are an athlete: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Race
This medicine may be less effective in lowering blood pressure in black patients compared to others.
Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the information under "Do not take Fosinopril and Hydrochlorothiazide Mylan Generics".
Other medicines and Fosinopril and Hydrochlorothiazide Mylan Generics
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Your treatment may be affected if Fosinopril and Hydrochlorothiazide Mylan Generics is taken together with certain other medicines.
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.
potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; 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 blood levels of potassium or magnesium.
non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. aspirin or indomethacin), as they may reduce the effect of Fosinopril and Hydrochlorothiazide Mylan Generics or increase the side effects of aspirin.
antacids containing magnesium or aluminium (for heartburn), which may reduce the effect of Fosinopril and Hydrochlorothiazide Mylan Generics. Therefore, you should wait two hours between taking Fosinopril and Hydrochlorothiazide Mylan Generics and antacids.
calcium salts and vitamin D: concomitant use with Fosinopril and Hydrochlorothiazide Mylan Generics may cause increased calcium levels.
insulin and oral antidiabetic medicines, as Fosinopril and Hydrochlorothiazide Mylan Generics may enhance their effect, 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 may enhance the blood pressure-lowering effect of Fosinopril and Hydrochlorothiazide Mylan Generics.
lithium (used for manic depression), as Fosinopril and Hydrochlorothiazide Mylan Generics may increase lithium blood levels.
digoxin and digitoxin, as Fosinopril and Hydrochlorothiazide Mylan Generics may increase their side effects.
medicines known as sympathomimetics, e.g. salbutamol, ephedrine, used to treat bronchitis or asthma, and some medicines used to treat cold, cough, or flu symptoms, as they may reduce the blood pressure-lowering effect of Fosinopril and Hydrochlorothiazide Mylan Generics.
adrenaline (epinephrine), as Fosinopril and Hydrochlorothiazide Mylan Generics 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 the number of certain blood cells. Additionally, you may need to increase the dose of some gout medicines such as allopurinol and benzbromarone, as hydrochlorothiazide causes increased uric acid levels.
cholestyramine or colestipol (used for high blood fat levels), as they may reduce the absorption of Fosinopril and Hydrochlorothiazide Mylan Generics.
curare-like muscle relaxants (e.g. tubocurarine), administered during surgery, as Fosinopril and Hydrochlorothiazide Mylan Generics may enhance their muscle-relaxing effect.
certain antiarrhythmics, certain antipsychotics, and other medicines known to cause torsade de pointes (a rapid, uncontrolled heartbeat) must not be taken simultaneously with Fosinopril and Hydrochlorothiazide Mylan Generics.
if you are taking ganglionic blockers or peripheral adrenergic receptor antagonists.
diazoxide, used to treat low blood glucose and high blood pressure.
results of certain laboratory tests such as digoxin assay (Kit RIA Digi-Tab), parathyroid tests, or protein-bound iodine (PBI) test may be affected.
medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section "Warnings and precautions".

Your doctor may consider it necessary to adjust the dose and/or take other precautions:

If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also information in section "Do not take Fosinopril and Hydrochlorothiazide Mylan Generics" and "Warnings and precautions").

Fosinopril and Hydrochlorothiazide Mylan Generics with food and drinks
If you drink alcohol while taking Fosinopril and Hydrochlorothiazide Mylan Generics, 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 Mylan Generics.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are pregnant (or if there is any possibility of becoming pregnant). Your doctor will usually advise you to stop taking Fosinopril and Hydrochlorothiazide Mylan Generics before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Fosinopril and Hydrochlorothiazide Mylan Generics 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.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Fosinopril and Hydrochlorothiazide Mylan Generics is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the 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 Mylan Generics.
Fosinopril and Hydrochlorothiazide Mylan Generics contains lactose
Fosinopril and Hydrochlorothiazide Mylan Generics contains lactose (see section 6 "Contents of the pack and other information"). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Fosinopril and Hydrochlorothiazide Mylan Generics contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Fosinopril and Hydrochlorothiazide Mylan 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 your doctor has told you. If you are not sure, 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.

Use in children and adolescents
The use of Fosinopril and Hydrochlorothiazide Mylan Generics is not recommended in children and adolescents under 18 years of age.

If you take more Fosinopril and Hydrochlorothiazide Mylan Generics than you should
Contact your doctor, the nearest emergency department, or a poison control centre immediately for advice.

If you forget to take Fosinopril and Hydrochlorothiazide Mylan Generics
Do not take the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Fosinopril and Hydrochlorothiazide Mylan Generics
Do not stop taking Fosinopril and Hydrochlorothiazide Mylan Generics unless your doctor has advised you to do so. If you stop taking Fosinopril and Hydrochlorothiazide Mylan Generics, your blood pressure may increase.

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.
Some side effects can be serious and require immediate medical attention:
Contact your doctor immediately if you experience any of the following symptoms:

A serious condition characterized by severe peeling and swelling of the skin, blistering affecting the skin, mouth, eyes, and genital organs, and fever. Skin rash characterized by pink-red patches, especially on the palms of the hands or soles of the feet, possibly with blister formation (erythema multiforme and toxic epidermal necrolysis are rare side effects, and the frequency of Stevens-Johnson syndrome is unknown).
A severe allergic reaction with swelling of the face, tongue, and throat, which may cause breathing difficulties (anaphylactic reaction is a rare side effect, and the frequency of angioedema is unknown).

Very common: may affect more than 1 in 10 people
High levels of sugar in the urine and blood, electrolyte imbalance (low potassium and sodium in the blood), increased blood lipids (cholesterol and triglycerides), elevated levels of uric acid in the blood.

Common: may affect up to 1 in 10 people
Upper respiratory tract infection (e.g. sore throat, sinusitis, common cold), headache, feeling of light-headedness, weakness, fatigue, dry cough, skin inflammation, increased heart rate (tachycardia), awareness of heartbeat (palpitations), stomach irritation, constipation, muscle and skeletal pain, reversible increase in substances normally eliminated in urine (creatinine, urea).

Uncommon: may affect up to 1 in 100 people
Confusion, ear pain, taste disturbances, loss of appetite, dry mouth, flatulence, runny nose, sinus inflammation (sinusitis), inflammation of the trachea and bronchi (tracheobronchitis), breathing difficulties, fever, tissue swelling, especially in the lower limbs (peripheral edema), sudden death, increased sweating, chest pain (not heart-related), weight gain, heart failure, heart rhythm disorders, reduced blood flow to the brain, tremors, transient decrease in hemoglobin, reduced number of red blood cells, reduced kidney function, increased blood pressure, shock, blood tests may show abnormalities (e.g. increased potassium), increased levels of protein in the urine.

Rare: may affect up to 1 in 1,000 people
Reactivation of cutaneous lupus erythematosus or drug-induced cutaneous lupus erythematosus (a disease in which the immune system attacks the body, causing joint pain, skin rashes, and fever), nosebleeds, laryngitis causing hoarseness or temporary complete loss of voice, pneumonia, oral lesions, tongue swelling, difficulty swallowing, swollen salivary glands (sialadenitis), joint inflammation, memory disorders, disorientation, language disorders, sleep disturbances, restlessness, stomach distension (bloating sensation), increase in certain types of white blood cells (eosinophils), reduced production of blood cells, bleeding (hemorrhage), circulation disorders in arms and legs (peripheral vascular disease), renal dysfunction, prostate disorders, weakness in a limb, slight increase in hemoglobin, hyponatremia.

Very rare: may affect up to 1 in 10,000 people
Acute kidney failure, intestinal angioedema (intestinal swelling), intestinal blockage (ileus), liver failure.

Not known: frequency cannot be estimated from available data
Skin and lip cancer (non-melanoma skin cancer), sore throat, anemia, changes in certain blood cells (leukopenia, neutropenia, agranulocytosis, thrombocytopenia), abnormal enlargement of lymph nodes, gout, reduced chloride, abnormally high levels of alkali in blood and body tissues, depression, drowsiness, skin tingling (paresthesia), reduced sense of touch (hypoesthesia), fainting, lack of strength, stroke, transient blurred vision, visual disturbances (objects may appear more yellow), decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), tinnitus (ringing in the ears), dizziness, changes in heart rhythm, chest pain, heart attack, low blood pressure, drop in blood pressure when standing up (may cause dizziness or fainting), muscle pain during exercise that disappears at rest, flushing, inflammation of blood vessels, sinus congestion, lung inflammation, fluid in the lungs, breathing difficulties (dyspnea), vomiting, diarrhea, stomach ache, feeling unwell, indigestion, inflammation of the pancreas (pancreatitis), inflammation of the stomach and/or esophagus, taste disturbances, yellowing of the skin and eyes (jaundice), liver inflammation, skin rash, hives, itching, photosensitivity, muscle pain, joint pain, red or purple spots on the skin, muscle spasms, frequent urination, difficulty urinating, kidney failure, sexual dysfunction, abnormal liver function tests (increased transaminases, lactate dehydrogenase in blood, alkaline phosphatase in blood, and bilirubin in blood), abnormal electrolyte values, uric acid, blood glucose, magnesium, cholesterol, triglycerides, and calcium in blood.

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 website 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 Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Do not store Fosinopril and Hydrochlorothiazide Mylan Generics above 25°C.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fosinopril and Hydrochlorothiazide Mylan Generics contains

The active substances are: fosinopril sodium and hydrochlorothiazide. Each tablet contains 20 mg of fosinopril sodium and 12.5 mg of hydrochlorothiazide.
The other components are: monohydrate lactose, sodium croscarmellose, pregelatinized starch (maize), glyceryl dibehenate, yellow iron oxide (E 172), red iron oxide (E 172) and titanium dioxide (E171).

Description of the appearance of Fosinopril and Hydrochlorothiazide Mylan Generics and package contents
Tablets, light orange in colour with some white specks, round, flat, 9 mm in diameter, marked with "FH" on one side.
Each pack contains 10, 14, 20, 30, 50, 60 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy
Manufacturer
Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Fosinopril- Natrium/HCT Actavis comp 20 mg/12,5 mg Tabletten
Estonia: Fosinopril HCT Actavis
Hungary: Fosicard Plus 20 mg/12,5 mg tabletta
Italy: Fosinopril e Idroclorotiazide Mylan Generics
Lithuania: Fosinopril HCT Actavis 20 mg/12,5 mg tabletes
Latvia: Fosinopril HCT Actavis 20 mg/12,5 mg tabletes
Slovenia: Fosicard HCT 20 mg/12,5 mg tablete

This leaflet was last updated on: