10 mg / 12.5 mg and 20 mg / 12.5 mg film-coated tablets
kinapril / hydrochlorothiazide

1. What Accupro comp is and what it is used for

Accupro comp includes two active substances: quinapril and hydrochlorothiazide. April causes the body to produce smaller amounts of certain blood pressure-raising substances, which have an astringent effect on blood vessels and which retain salt and water in the body. The blood pressure-lowering effect of quinapril usually occurs within an hour is greatest after 2-4 hours and lasts about a day.

Hydrochlorothiazide has a diuretic and antihypertensive effect. The decrease in blood pressure is partly due to the diuretic effect, but probably also due to the dilation of certain blood vessels. The increased urinary excretion due to hydrochlorothiazidebegins about 2 hours after taking a dose, is greatest after about 4 hours and lasts about 12 hours.

2. What you need to know before taking Accupro comp

Do not take Accupro comp

  • if you are allergic to quinapril hydrochloride or other ACE inhibitors, hydrochlorothiazide or other sulphonamide derivatives, or any of the other ingredients of this medicine (listed in section 6).
  • during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Accupro comp, see Pregnancy and breast-feeding.)
  • if you have previously had swelling ( angioedema ) of i.a. face, lips, tongue, and/or throat in connection with treatment with ACE inhibitors or for some other unknown reason, or if someone in your family has had angioedema (the condition may be hereditary).
  • if you have severe renal impairment.
  • if you have an obstruction in the outflow from the heart
  • if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
  • if you are taking a heart failure medicine containing sacubitril/valsartan.

Warnings and cautions

Talk to your doctor or pharmacist before taking Accupro comp:

– if you have had skin cancer or if you get an unforeseen skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin and lip cancer (non–melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Accupro-comp.

– if you have narrowing of the large carotid artery.

– if you have or have had any form of asthma.

– if you have prolonged diarrhea or vomiting.

– if you are taking potassium supplements, potassium-sparing medicines, other medicines that are known to increase the levels of potassium in the blood, potassium-containing salt replacement, or if you have been prescribed a low-salt diet.

– if you are using diuretics ( diuretics ). Your doctor may decide to stop your diuretic treatment and correct your fluid and salt balance before starting treatment with Accupro comp.

– if you have a weak heart ( heart failure ) or any heart disease (eg some heart defects or thickening of the heart muscle). Your doctor may need to check you and change the dose of the medicine.

– if you have liver disease, impaired kidney function, or if you have had a kidney transplant. Your doctor may need to check you and change the dose of the medicine.

– if you have diabetes. You may need to check your blood sugar more often during the first month of treatment as Accupro comp may cause low blood sugar. Your doctor may in some cases recommend that you take potassium supplements.

– severe allergic reactions may occur if Accupro comp is used in the treatment of hypersensitivity to bee or wasp venom ( hyposensitization ). Tell your doctor if you are going to undergo such treatment.

– ACE inhibitors can cause dry cough which, however, disappears when you stop taking the medicine.

– if you are receiving hemodialysis. Tell your doctor so that a technique can be chosen that does not give you a hypersensitivity reaction.

– if you are undergoing a procedure to remove bad cholesterol from your blood (so-called LDL apheresis), you should not use Accupro comp. This is to avoid hypersensitivity reactions.

– if you have had a drug reaction in the skin and mucous membranes ( Stevens-Johnson syndrome ).

– if you have SLE (systemic lupus erythematosus, an autoimmune disease).

– if you are being treated with medicines that affect the immune system, allopurinol (medicines for gout ) or procainamide.

– if you are taking any of the following medicines used to treat high blood pressure:

– an angiotensin II receptor blocker (ARB) (also known as sartans – eg valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems

– aliskiren.

Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals. See also the information under the heading “Do not take Accupro comp”.

Before surgery and anesthesia (also applies to the dentist), the doctor/dentist should know that you are being treated with Accupro comp, as there is a risk that the blood pressure will drop sharply during anesthesia.

If you are going to have a test for your parathyroid function, your doctor should know that you are being treated with Accupro comp.

Ethnic differences: Like other ACE inhibitors, April may be less effective in blacks than in non-black

Contact a doctor immediately if you experience symptoms such as sudden visual acuity or eye pain. The symptoms usually occur within hours to weeks after the start of Accuretic and may indicate excess fluid in the eye (between choroid and sclera) or acute transient myopia and a form of acute glaucoma ( angle-closure glaucoma ). This can lead to permanent loss of vision if left untreated. If you have had a hypersensitivity reaction to penicillin or sulfonamide, you may be at greater risk of developing this.

If you think you may be pregnant or become pregnant during treatment, consult your doctor. Accupro comp is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects, see Pregnancy and breast-feeding.

Other medicines and Accupro comp

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

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

  • antibiotics of the type tetracycline s because the effect of tetracycline s may decrease.
  • other antihypertensive drugs such as nitrates (used to treat coronary heart disease) and other antihypertensive drugs. Drugs used in connection with anesthesia can also have this blood pressure-lowering effect.
  • potassium-sparing diuretics (eg spironolactone, triamterene, or amiloride) and potassium supplements as potassium levels in the blood may be too high. Trimethoprim (an antibiotic for eg urinary tract infection) can also increase the level of potassium in the blood.
  • diuretics ( diuretics, such as thiazides or loop diuretics) as the antihypertensive effect of Accupro comp may be increased.
  • lithium (used for manic depressive disorders).
  • analgesics ( NSAIDs ) such as acetylsalicylic acid, ibuprofen, or ketoprofen.
  • adrenaline can reduce the effect of Accupro comp.
  • diabetes drugs (both insulin and oral drugs).
  • neutralizing stomach medicine (antacids) may reduce the effect of Accupro comp.
  • medicines for gout (eg allopurinol).
  • procainamide (used to treat heart arrhythmias ), anticancer medicines, or medicines that inhibit the body’s immune system (immunosuppressive).
  • carbenoxolone (medicine for oesophagitis), corticosteroids (medicines that reduce inflammation ), corticotropin (ACTH, a hormone ), or certain laxatives as potassium levels in the blood may decrease.
  • digoxin (heart medicine) as it is especially important to keep potassium and magnesium levels at a normal level if you are taking these medicines.
  • drugs that can affect the heart rhythm ( Torsades de pointes ).
  • resins against elevated cholesterol such as cholestyramine and colestipol.

Your doctor may need to change your dose and/or take other precautions if you are taking angiotensin II receptor blockers (ARBs) or aliskiren (see also the information under the headings “Do not take Accupro comp” and “Warnings and precautions”).

Accupro comp with food, drink, and alcohol

Accupro comp can be taken regardless of the meal. Alcohol can lower blood pressure and make you feel tired or dizzy. Tell your doctor if you have been on a low-salt diet.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you think you may be pregnant or become pregnant during treatment, consult your doctor. Usually, your doctor will suggest that you stop taking Accupro comp before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you.

Accupro comp should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects.

Breast-feeding

Tell your doctor if you are breast-feeding or planning to start breast-feeding. Accupro comp is not recommended for breast-feeding.

Driving and using machines

Accupro comp may impair the ability to react. This should be taken into account when sharper attention is required, e.g. driving or precision work.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Accupro comp contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Accupro Comp

Always take Accupro comp exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The usual dose for adults is between one 10 mg / 12.5 mg tablet and one 20 mg / 12.5 mg tablet daily.

If you forget to take Accupro comp

Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Accupro comp and contact your doctor immediately if you get any of the following less common side effects ( angioedema ):

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing.

It has been reported that Accupro comp can affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.

The following other side effects have been reported:

Common (affects more than 1 user in 100):

Elevated potassium levels in the blood, increased levels of urea in the blood, increased levels of serum creatinine, insomnia, fatigue, weakness, dizziness, headache, extreme drowsiness, dilation of blood vessels, inflammation of the trachea ( bronchitis ), cough, pharyngitis, rhinitis ), infection of the upper respiratory tract, increased levels of uric acid in the blood, gout, chest pain, chest pain ( angina pectoris ), palpitations, stomach pain, diarrhea, gastritis ( dyspepsia ), nausea, vomiting, back pain, muscle pain.

Uncommon (affects less than 1 user in 100):

Confusion, depression, anxiety, “ant crawls” ( paresthesias ), TIA (transient ischemic attacks), visual disturbance (amblyopia), tinnitus, vertigo, heart attack, low blood pressure, fainting, shortness of breath, sinusitis, flatulence, mouth or throat, altered taste, hair loss, photosensitivity reaction, itching, rash, increased transpiration, joint pain ( arthralgia ), renal impairment, protein “egg white” in the urine, urinary tract infection, impotence, fever, general or localized body swelling, viral infection, impaired glucose tolerance.

Rare (affects less than 1 user in 1,000):

Balance disorder, allergic pneumonia ( eosinophilic pneumonitis ), constipation, heartburn, skin changes in combination with fever, muscle aches, and joint pain, vasculitis ( vasculitis ), psoriasis-like skin inflammation.

Very rare (affects less than 1 user in 10,000):

Blurred vision, ileus, allergic reaction in the small intestine (intestinal angioedema ) which can cause symptoms such as abdominal pain, nausea, and vomiting, hives, or hives ( urticaria ).

No known frequency (cannot be calculated from the available data):

Pronounced increase in the number of white blood cells in the blood, decreased number of platelets in the blood, acute and severe allergic reaction (anaphylactic), cerebral haemorrhage, impaired vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) , sudden myopia or glaucoma ), irregular heartbeat ( arrhythmia ), sudden drop in blood pressure when getting up, respiratory cramps, inflammation of the pancreas, inflammation of the liver ( hepatitis), obstruction of the bile duct (cholestatic jaundice), severe widespread skin damage (skin detachment), skin and mucosal changes (sometimes severe), skin and lip cancer (non- melanoma skin cancer), circular raised rash (erythema multiforme), blistering of the skin and mucous membranes ( pemphigus ), bluish-purple spots similar to bruises (purpura), systemic lupus erythematosus ( SLE , an autoimmune disease), increased levels of cholesteroland triglycerides , decreased levels of hematocrit and increased levels of liver enzymes and blood bilirubin, increased levels of antinuclear, antinuclear increased rate of red blood cell sedimentation, in patients with congenital G-6 PDH deficiency, isolated cases of haemolytic anemia ( anemia ) have been reported.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Accupro comp

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 carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

– The active substances are quinapril hydrochloride and hydrochlorothiazide.

Accupro comp 10 mg / 12.5 mg contains quinapril hydrochloride equivalent to 10 mg quinapril and 12.5 mg hydrochlorothiazide .

Accupro comp 20 mg / 12.5 mg contains quinapril hydrochloride equivalent to 20 mg quinapril and 12.5 mg hydrochlorothiazide .

The other ingredients are lactose monohydrate, magnesium subcarbonate (heavy), magnesium stearate, crospovidone, povidone, hypromellose, hydroxypropyl cellulose, macrogol 400, candelilla wax, titanium dioxide (E 171), red and yellow iron oxide (E 172).

What the medicine looks like and the contents of the pack

Appearance:

10 mg / 12.5 mg tablets are pink, elliptical, and scored.

20 mg / 12.5 mg tablets are pink, triangular, and scored.

Pack sizes:

Tablets 10 mg / 12.5 mg: Blister pack of 30 resp. 100 tablets.

Tablets 20 mg / 12.5 mg: Blister pack of 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pfizer AB

191 90 Sollentuna

Tel: 08-550 520 00

Email: eumedinfo@pfizer.com

Muhammad Nadeem

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