Quinapril and hydrochlorothiazide Mylan Generics

PATIENT INFORMATION LEAFLET

Quinapril and Hydrochlorothiazide Mylan Generics 10 mg/12.5 mg film-coated tablets

Quinapril and Hydrochlorothiazide Mylan Generics 20 mg/12.5 mg film-coated tablets
Quinapril and Hydrochlorothiazide Mylan Generics 20 mg/25 mg film-coated tablets
Quinapril and Hydrochlorothiazide
Generic Medicine
Read this entire leaflet carefully before you start 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. Never give it to others, 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 Quinapril and Hydrochlorothiazide Mylan Generics is and what it is used for
2. What you need to know before taking Quinapril and Hydrochlorothiazide Mylan Generics
3. How to take Quinapril and Hydrochlorothiazide Mylan Generics
4. Possible side effects
5. How to store Quinapril and Hydrochlorothiazide Mylan Generics
6. Package contents and other information

1. WHAT QUINAPRIL AND HYDROCHLOROTHIAZIDE MYLAN GENERICS IS AND WHAT IT IS USED FOR

Quinapril and Hydrochlorothiazide Mylan Generics contains two active substances: quinapril and hydrochlorothiazide.
Quinapril reduces the formation of substances in the body that increase blood pressure. These substances cause constriction of blood vessels and also lead to retention of salts and water in the body. Quinapril belongs to a group of medicines called ACE inhibitors.
Hydrochlorothiazide has a diuretic and blood pressure-lowering effect and belongs to a group of medicines called thiazides (sulfonamides).
Quinapril and Hydrochlorothiazide Mylan Generics is used to treat high blood pressure when combined treatment with an ACE inhibitor (quinapril) and a diuretic (hydrochlorothiazide) is considered appropriate.

2. WHAT YOU SHOULD KNOW BEFORE TAKING QUINAPRIL AND HYDROCHLOROTHIAZIDE MYLAN GENERICS

GENERICS
Do not take Quinapril and Hydrochlorothiazide Mylan Generics:

• if you are allergic (hypersensitive) to quinapril, to other ACE inhibitors, to hydrochlorothiazide, to other medicines containing sulfonamides, or to any of the other excipients of Quinapril and Hydrochlorothiazide Mylan Generics (listed in section 6);
• if you have previously experienced swelling of the legs, arms, face, mucous membranes, or tongue (angioedema) during treatment with an ACE inhibitor or for any unknown reason, or if you or a family member has had angioedema (this condition may be hereditary);
• if you suffer from severe impairment of liver function;
• if you have severe kidney problems or are experiencing urinary tract problems (anuria);
• if you have a heart obstruction that slows blood flow to the heart (ventricular outflow obstruction);
• if you are more than 3 months pregnant. (It is also advisable to avoid Quinapril and Hydrochlorothiazide Mylan Generics in early pregnancy – see also 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, such as in the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking Quinapril and Hydrochlorothiazide Mylan Generics:

• if you have previously had skin cancer or are developing 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 and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Quinapril 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 in the eye, which may occur from a few hours to several weeks after taking Quinapril and Hydrochlorothiazide Mylan Generics. If untreated, this condition may lead to permanent vision impairment. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.
• 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 – e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

If you are taking any of the following medicines, the risk of angioedema (rapid subcutaneous swelling, such as 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.

See also the information in section "Do not take Quinapril and Hydrochlorothiazide Mylan Generics".
You must inform your doctor of any medical conditions you currently have or have had in the past, especially:

• if you suffer from aortic stenosis (narrowing of the main blood vessels), low blood pressure, heart disease, or other heart problems (e.g., heart failure);
• if you experience prolonged episodes of diarrhoea or vomiting;
• if you are taking potassium supplements, potassium-sparing medicines, potassium-containing salt substitutes, or if you have been prescribed a low-salt diet;
• if you are taking diuretic medicines. Your doctor may stop your diuretic therapy and correct low blood volume and/or salt levels before starting treatment with Quinapril and Hydrochlorothiazide Mylan Generics;
• if you have heart weakness (heart failure), or heart disease (e.g., certain heart valve defects or thickening of the heart muscle). Your doctor may perform checks and adjust your medicine dose;
• if you have liver disease, reduced liver function, or have undergone a kidney transplant. Your doctor may perform checks and adjust your medicine dose;
• if you have diabetes. More frequent blood glucose monitoring may be needed during the first month of treatment. See also section “Taking Quinapril and Hydrochlorothiazide Mylan Generics with other medicines”;
• if you are undergoing treatment for hypersensitivity to bee or wasp stings (desensitization therapy);
• if you are undergoing haemodialysis. Inform your doctor so that a technique avoiding hypersensitivity reactions can be chosen;
• if you are undergoing a procedure to remove “bad” cholesterol from your blood (so-called LDL apheresis), you must not take Quinapril and Hydrochlorothiazide Mylan Generics to avoid hypersensitivity reactions;
• if you have blood vessel diseases such as scleroderma or Raynaud's phenomenon;
• if you are taking medicines that affect the immune system, allopurinol (a medicine for gout), or procainamide;
• if you have allergies or asthma;
• if you have previously suffered from angioedema (erythema followed by facial swelling that can be severe enough to cause breathing difficulties);
• if you have systemic lupus erythematosus (SLE). An immune system-related inflammatory condition causing joint pain, skin rashes, and fever;
• you must inform your doctor if you think you are (or could be) pregnant. Quinapril and Hydrochlorothiazide Mylan Generics is not recommended in early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the unborn child at this stage (see section “Pregnancy”).

Before undergoing surgical procedures or anaesthesia (including dental treatment), your doctor or dentist must be informed that you are being treated with Quinapril and Hydrochlorothiazide Mylan Generics, as there is a risk that your blood pressure may drop drastically during anaesthesia.
Cough has been reported with the use of ACE inhibitors. Inform your doctor if you develop a cough during treatment with Quinapril and Hydrochlorothiazide Mylan Generics.
The hydrochlorothiazide contained in this medicine may cause positive anti-doping test results.
For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Ethnic differences: people of Black race are more likely to experience severe allergic reactions when taking Quinapril and Hydrochlorothiazide Mylan Generics. Like other ACE inhibitors, quinapril may be less effective in people of Black race than in those of non-Black race.

Children and adolescents
The efficacy and safety of use in children have not been established. Therefore, use in children and adolescents is not recommended.

Other medicines and Quinapril and Hydrochlorothiazide Mylan Generics
Some medicines may affect or be affected by Quinapril and Hydrochlorothiazide Mylan Generics. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
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 sections "Do not take Quinapril and Hydrochlorothiazide Mylan Generics" and "Take special care with Quinapril and Hydrochlorothiazide Mylan Generics").

It is particularly important for your doctor to know if you are already being treated with any of the following medicines:

• tetracycline-type antibiotics, as their effect may be reduced;
• other medicines that lower blood pressure, such as nitrates used in coronary artery disease, or other blood pressure-lowering medicines. Tricyclic antidepressants, medicines used to treat psychosis, and medicines used in combination with anaesthetics may also lower blood pressure;
• potassium supplements (including salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene, amiloride), angiotensin receptor blockers, and other medicines that may increase potassium levels in your blood (such as trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole for treating bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting);
• diuretics (such as thiazides and loop diuretics), as the blood pressure-lowering effect of Quinapril and Hydrochlorothiazide Mylan Generics may be increased;
• lithium (used to treat manic-depressive illness);
• painkillers (NSAIDs, non-steroidal anti-inflammatory drugs) such as acetylsalicylic acid (aspirin), ibuprofen, or ketoprofen, taken regularly and for long periods (Note: low doses of acetylsalicylic acid to prevent clotting may be safely used with Quinapril and Hydrochlorothiazide Mylan Generics);
• certain asthma medicines and adrenaline, which may reduce the effect of Quinapril and Hydrochlorothiazide Mylan Generics;
• antidiabetic medicines (both insulin and oral preparations). Quinapril and Hydrochlorothiazide Mylan Generics may enhance the antidiabetic effect;
• antacids (medicines for heartburn), which may reduce the effect of Quinapril and Hydrochlorothiazide Mylan Generics;
• allopurinol (used to treat gout), procainamide (used to treat irregular heartbeat), anticancer medicines, or medicines that suppress the immune system (immunosuppressants);
• amphotericin B (a medicine for fungal infections), carbenoxolone (a medicine for throat inflammation), corticosteroids (medicines for treating inflammation), corticotropin (ACTH, a hormone), heart medicines (digitalis), or certain laxatives, as these may reduce potassium levels in the body;
• calcium salts, as calcium levels in the body may increase;
• certain medicines used to treat high blood fat levels (cholestyramine and colestipol), as the effect of Quinapril and Hydrochlorothiazide Mylan Generics may be reduced if taken simultaneously;
• muscle relaxants (tubocurarine chloride), as their effect may be enhanced;
• medicines that may cause "torsades de pointes" (affecting heart rhythm);
• sacubitril/valsartan, a medicine used to treat chronic heart failure in adults. See section “Do not take Quinapril and Hydrochlorothiazide Mylan Generics”;
• medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other drugs belonging to the mTOR inhibitor class). See section “Warnings and precautions”;
• DPP-IV inhibitors such as vildagliptin (a medicine used to treat diabetes). See section “Warnings and precautions”;
• racecadotril, a medicine used to treat diarrhoea. See section “Warnings and precautions”;
• digoxin (a medicine used to treat certain heart conditions).

Taking Quinapril and Hydrochlorothiazide Mylan Generics with food and drinks
Quinapril and Hydrochlorothiazide Mylan Generics can be taken regardless of meals. If you consume alcohol with Quinapril and Hydrochlorothiazide Mylan Generics, you may experience dizziness or faintness, fatigue, or weakness, as the medicine may significantly lower your blood pressure.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are (or could be) pregnant. Your doctor will usually advise you to stop treatment with Quinapril and Hydrochlorothiazide Mylan Generics before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
Quinapril and Hydrochlorothiazide Mylan Generics is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the unborn child if used beyond the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Quinapril and Hydrochlorothiazide Mylan Generics is not recommended for breastfeeding mothers.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Quinapril and Hydrochlorothiazide Mylan Generics may affect your ability to drive or operate machinery safely. Dizziness or fatigue may occur.

Important information about some excipients of Quinapril and Hydrochlorothiazide Mylan Generics:
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. HOW TO TAKE QUINAPRIL AND HYDROCHLOROTHIAZIDE MYLAN GENERICS

Always take Quinapril and Hydrochlorothiazide Mylan Generics exactly as instructed by
your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual dose is 10 mg of quinapril and 12.5 mg of hydrochlorothiazide (one tablet of
Quinapril and Hydrochlorothiazide Mylan Generics 10 mg/12.5 mg) taken in the morning. The maximum dose is
20 mg of quinapril and 25 mg of hydrochlorothiazide (one tablet of Quinapril and Hydrochlorothiazide
Mylan Generics 20 mg/25 mg).
If you are elderly or have impaired kidney function, your doctor may decide to use a lower dose.
Quinapril and Hydrochlorothiazide Mylan Generics must not be used in children.
The tablets should be taken with half a glass of water.
If you take more Quinapril and Hydrochlorothiazide Mylan Generics than you should
Contact a doctor, the Emergency Department of the nearest hospital, or a Poison Control Centre immediately for advice.
Overdose may cause symptoms such as low blood pressure with dizziness and fainting.
If you forget to take Quinapril and Hydrochlorothiazide Mylan Generics
Do not take a double dose to make up for the missed dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Quinapril and Hydrochlorothiazide Mylan Generics can cause adverse reactions, although not everyone experiences them.

If you notice any of the following side effects, stop taking Quinapril and
Hydrochlorothiazide Mylan Generics and contact your doctor immediately.
Common

• Heart attack. Symptoms include chest pain, tightness in the chest, shortness of breath or difficulty breathing

Uncommon

• Chest pain
• Mini-stroke (transient ischaemic attack)
• A severe allergic reaction with swelling of the face, tongue or throat, which may cause severe breathing difficulties (angioedema)

Very rare

• Swelling of the intestine causing symptoms such as stomach pain, discomfort and vomiting (intestinal angioedema)
• Bowel obstruction

Not known

• Anaemia causing shortness of breath or pale appearance
• Bleeding or bruising more easily than normal due to a reduced number of platelets (thrombocytopenia)
• Severe and widespread red skin rash with blisters (including Stevens-Johnson syndrome and toxic epidermal necrolysis)
• A sudden allergic reaction with shortness of breath, rash, wheezing and drop in blood pressure (anaphylactoid reaction)
• Quinapril and Hydrochlorothiazide Mylan Generics may reduce the number of white blood cells in your blood and may decrease your resistance to infections. If you develop an infection with symptoms such as fever and a severe worsening of your general condition, or fever with signs of a local infection such as sore throat/pharynx/mouth or urinary problems, you must contact your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important to inform your doctor about your medications. Heart attack, chest pain, infarction or mini-infarction may be caused by a severe drop in blood pressure.

The following side effects have also been reported.
Common

• Difficulty sleeping
• Dizziness
• Inflammation of the airways, cough
• Infections of the nose and throat, bronchitis
• Stuffy nose and/or runny nose (rhinitis)
• Feeling unwell, nausea, diarrhoea, indigestion, stomach ache
• Headache, fatigue, drowsiness, weakness
• Muscle pain, back pain, chest pain
• Increased levels of uric acid in the blood causing swelling, painful joints (gout)
• Increased potassium levels in the blood
• Changes in blood test results indicating how the kidneys are functioning
• Blood vessel dilation
• Irregular or forceful heartbeat (palpitations), rapid heartbeat (tachycardia)

Uncommon

• Kidney and urinary tract problems, urinary tract infections
• Fluid retention causing tissue swelling
• Confusion, nervousness, depression
• Feeling of dizziness or lightheadedness
• Development of diabetes (diabetic patients may need to adjust their diabetes treatment)
• Impaired glucose tolerance
• Tingling sensation (pins and needles)
• Altered taste, lazy eye, ringing in the ears (tinnitus)
• Low blood pressure, fainting
• Shortness of breath, sinus inflammation (sinusitis)
• Dry mouth or dry throat
• Skin rash, increased skin sensitivity to light, itching, hair loss
• Joint pain
• Fever, increased sweating
• Viral infection
• Sexual dysfunction
• Gas (flatulence)

Rare

• Balance problems
• Constipation
• Inflammation of the tongue
• Inflammation of the lungs which may cause breathlessness, cough and increased temperature
• Inflammation of blood vessels (vasculitis)
• Fever, muscle and joint pain associated with skin problems
• Psoriasis-like rash

Very rare

• Hives (urticaria)
• Blurred vision

Not known

• Narrowing of the airways in the lungs (bronchospasm)
• Inflammation of the pancreas causing abdominal pain
• Liver problems which may cause jaundice (yellowing of the skin and whites of the eyes)
• Changes in blood test results indicating how the liver is functioning
• Increased blood cholesterol and triglycerides
• Decrease in haematocrit and white blood cells
• Increased erythrocyte sedimentation rate
• Increase in anti-nuclear antibodies
• Skin discoloration
• Drop in blood pressure when standing up
• Bleeding from blood vessels in the brain
• Inflammation of the kidneys
• Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• Irregular heartbeat (arrhythmia)
• Increase in certain types of white blood cells (eosinophilia)
• Systemic lupus erythematosus (a disease affecting the skin, joints and kidneys)
• Serositis (a disease of the serous membranes)
• Skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects
If you experience any side effects, 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
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 QUINAPRIL AND HYDROCHLOROTHIAZIDE MYLAN GENERICS

Do not store above 25°C.
Blister pack: keep the medicine in the original packaging to protect it from moisture.
Keep out of the reach and sight of children.
Do not use Quinapril and Hydrochlorothiazide Mylan Generics after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Quinapril and Hydrochlorothiazide Mylan Generics contains
The active substances are quinapril hydrochloride and hydrochlorothiazide.
Quinapril and Hydrochlorothiazide Mylan Generics 10/12.5 mg contains quinapril hydrochloride
equivalent to 10 mg of quinapril and 12.5 mg of hydrochlorothiazide.
Quinapril and Hydrochlorothiazide Mylan Generics 20/12.5 mg contains quinapril hydrochloride
equivalent to 20 mg of quinapril and 12.5 mg of hydrochlorothiazide.
Quinapril and Hydrochlorothiazide Mylan Generics 20/25 mg contains quinapril hydrochloride
equivalent to 20 mg of quinapril and 25 mg of hydrochlorothiazide.
The other excipients are: Heavy magnesium carbonate, Calcium hydrogen phosphate, Pregelatinized maize starch, Sodium croscarmellose, Magnesium stearate, Hydroxypropylcellulose, Hypromellose, Titanium dioxide (E171), Macrogol, Yellow iron oxide (E172), Red iron oxide (E172).

Description of the appearance of Quinapril and Hydrochlorothiazide Mylan Generics and pack contents
Quinapril and Hydrochlorothiazide Mylan Generics 10/12.5 mg film-coated tablets:
Oval, pink, biconvex tablet, with a break line on both sides and engraved with “I” on one side. Dimensions: 4.5 x 8.7 mm.
Quinapril and Hydrochlorothiazide Mylan Generics 20/12.5 mg film-coated tablets:
Oval, pink, biconvex tablet, with a break line on both sides and engraved with “I” on one side. Dimensions: 5.8 x 11.3 mm.
Quinapril and Hydrochlorothiazide Mylan Generics 20/25 mg film-coated tablets:
Round, pink, biconvex tablet, with a break line on both sides and engraved with “I” on one side. Diameter: 8.5 mm.
The tablets can be divided into two equal parts.
Pack sizes: Blister packs containing 14, 28 or 56 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 Milan
Italy

Manufacturer responsible for batch release:
Doppel Farmaceutici S.r.l., Via Volturno 48, 20089 Quinto de’ Stampi, Rozzano (MI), Italy

This summary of product characteristics was last approved on