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Package leaflet: Information for the user

Kinoprilam 5 mg, 10 mg, 20 mg, 40 mg film-coated tablets

Quinapril

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Kinoprilam is and what it is used for

Kinoprilam contains the active substance quinapril. Kinoprilam belongs to a group of medicines that are known as antihypertensives. Antihypertensives are medicines that are used to treat high blood pressure.

Kinoprilam is a type of antihypertensive known as an angiotensin converting enzyme inhibitor (ACE inhibitor). ACE inhibitors lower blood pressure by blocking a substance called angiotensin, which tightens blood vessels. Blocking angiotensin allows the blood vessels to relax, which in turn lowers blood pressure.

Kinoprilam is used to treat:

• high blood pressure

• congestive heart failure (when the heart cannot pump enough blood around the body).

2. What you need to know before you use Kinoprilam

DO NOT use Kinoprilam if you:

• Are allergic to quinapril or any of the other ingredients of this medicine (listed in section 6)

• Are allergic to any other ACE inhibitor

• Have developed severe allergic (hypersensitivity) reactions after previous treatment with an ACE inhibitor. Symptoms of severe allergic reactions include swelling of the extremities, face, lips, tongue and/or throat (angioedema) with difficulty in swallowing or breathing

• Suffer from hereditary or unexplained angioedema

• If you are more than 3 months pregnant. (It is also better to avoid Kinoprilam in early pregnancy, - see pregnancy section.)

• If you have an obstruction in your heart that slows the flow of blood out of your heart (left ventricular outflow obstruction).

• If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warnings and precautions

Talk to your doctor or pharmacist before taking Kinoprilam.

You must tell your doctor if you think that you are (or might become) pregnant. Kinoprilam is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Before you take this medicine tell your doctor if you have now or have had in the past:

• Ischaemic heart disease (where your heart muscle has a reduced blood supply)

• Narrowing of your heart valves (aortic or mitral stenosis)

• Increase in the thickness of the heart muscle (hypertrophic cardiomyopathy)

• Ischaemic cerebrovascular disease (where your brain has a reduced blood supply)

• Kidney disease

• Narrowing of the kidney arteries (renal artery stenosis)

• Collagen vascular disease (a disease which affects the blood vessels)

• Diabetes

• Heart failure

• A type of high blood pressure called severe renin-dependent hypertension

• Liver failure

• Extremely low numbers of white blood cells (neutropenia / agranulocytosis)

• High levels of potassium in the blood

• Sensitivity reactions with or without a history of allergy or bronchial asthma

Take special care and tell your doctor if you are being given one of the following treatments:

• Haemodialysis (when your blood is cleaned of waste products using a dialysis machine)

• Other types of surgery or anaesthesia

• A technique called apheresis (to remove fat from your blood)

• Kidney transplant

• Desensitisation therapy (when you are given small amounts of a substance to which you are allergic to help reduce the negative effects, e.g. wasp stings)

• an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.

• aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Kinoprilam”

Symptomatic low blood pressure

In some cases Kinoprilam may cause your blood pressure to drop too low. This is more likely if you are dehydrated (your body does not have as much water and fluids as it should) e.g. by diarrhoea and vomiting. In this case your doctor will take action to increase your blood pressure to a safe level.

Ethnic differences

If you are black, Kinoprilam may be less effective in lowering your blood pressure. Black patients are more likely to get angioedema (swelling of face, tongue or throat and skin reactions) compared to non-black patients.

Other medicines and Kinoprilam

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You must take special care if you are also taking any of the following medicines:

• Tetracyclines (a type of antibiotic) and other drugs that interact with magnesium: Kinoprilam reduces the activity of these drugs. This combination should be avoided.

• Potassium-sparing diuretics (drugs which increase the amount of water you pass in your urine) or potassium supplements (vitamins and minerals containing potassium): Kinoprilam may reduce the activity of these substances.

• Diuretics (drugs which increase the amount of water you pass in your urine): Prior treatment with these drugs may increase the activity of Kinoprilam on your blood pressure. When Kinoprilam is used to treat chronic heart failure, it is likely that it will reduce the effects of furosemide (a loop diuretic).

• Other drugs to reduce blood pressure: These drugs may increase the effect of Kinoprilam on blood pressure.

• Lithium (a medicine used for mental disorders): Kinoprilam may increase the toxicity (side effects) of lithium.

• Tricyclic antidepressants (for depression) and Antipsychotics (for mental illness): These may increase the activity of Kinoprilam.

• Non-steroidal anti-inflammatory drugs (rheumatism drugs): These may decrease the activity of Kinoprilam. They might also cause kidney problems.

• Acetylsalicylic acid: If you take high doses of acetylsalicylic acid (over 325 mg) it is likely that this will reduce the effects of Kinoprilam.

• Sympathomimetics (a type of stimulant, including clonidine and dobutamine): These may decrease the activity of Kinoprilam.

• Drugs for diabetes: The activity of these drugs may be increased by Kinoprilam.

• Trimethoprim: Treatment with trimethoprim and Kinoprilam at the same time can cause severely raised levels of potassium in your blood.

• Antacids: Antacids reduce the effect of Kinoprilam.

• Alcohol, anaesthetic medicines (tell your doctor if you are going to have an operation) and narcotics (strong painkillers or sleeping tablets): These drugs may increase the effect of Kinoprilam on blood pressure.

• Allopurinol (to treat chronic gout), cytostatic (cancer therapy) and immunosuppressive agents (for the treatment of autoimmune diseases or used to prevent rejection of organ transplants), corticosteroids (anti-inflammation medicines,) or procainamide (used to correct irregular heartbeats): These drugs may lead to an increased risk for leucopenia (abnormal reduction in the number of white blood cells in the blood).

• Gold: Nitritoid reactions (symptoms include facial flushing, nausea, vomiting, and hypotension) have been reported rarely in patients on therapy with injectable gold and an ACE- inhibitor.

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Kinoprilam” and “Warnings and precautions”)

Kinoprilam with food, drink and alcohol

Kinoprilam can be taken with or without food.

Alcohol may increase the effect of Kinoprilam and make your blood pressure too low.

Pregnancy and breast-feeding

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

You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Kinoprilam before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Kinoprilam. Kinoprilam is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third months of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Breast-feeding newborn babies (first few weeks after birth), and especially premature babies, is not recommended whilst taking Kinoprilam.

In the case of an older baby your doctor should advise you on the benefits and risks of taking Kinoprilam whilst breast-feeding, compared with other treatments.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

When taking Kinoprilam dizziness or weariness may occasionally occur. If you experience these symptoms you should not drive or use machines

3. How to use Kinoprilam

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

If your doctor has told you to take half a dose the tablets can be broken into two pieces on the score line.

Kinoprilam can be taken with or without food. The tablets should be swallowed with a drink of water.

Use in children and adolescents

Kinoprilam is not recommended for use in children or adolescents.

Adults

If you take Kinoprilam only (monotherapy) for high blood pressure

Your dose may be adjusted, depending on your response. If you do not feel better after 3 to 4 weeks, your dose can be increased by your doctor. Kinoprilam is usually taken once daily, although you may need to take it twice daily.

* This strength cannot be used for the starting dose.

If you take Kinoprilam in combination with a diuretic medicine (combination therapy)

You should take care because you are more likely to suffer symptoms of hypotension (low blood pressure).

Your doctor may ask you to stop taking your diuretic medicine if possible 2 to 3 days before you start taking Kinoprilam.

If you cannot stop taking your diuretic medicine, your first dose should be 2.5 mg. Your dose should then be adjusted by your doctor until the best response is achieved.

Your doctor will check that your kidneys are working properly and that you have the right amount of potassium in your blood.

If necessary your doctor may tell you to start taking your diuretic medicine again.

If you take Kinoprilam for heart failure

You will receive Kinoprilam in addition to, or combined with a diuretic medicine (water tablet) and/or digitalis (digoxin), a heart medicine.

You may begin treatment as an outpatient. However, if you have:

• severe or unstable heart failure

• your kidneys are not working well

• low volume of circulating fluid (plasma)

• not enough sodium in the blood (salt depletion)

• low blood pressure [systolic blood pressure (when the chambers of the heart are contracting) of less than 90 mm Hg]

• you are given Kinoprilam together with other vasodilating agents and high dose loop diuretics (more than 80 mg furosemide)

• if you are 70 years old or over

then you should be given Kinoprilam in hospital.

The starting dose is 2.5 mg Kinoprilam. After this dose your doctor will monitor your blood pressure to make sure it does not fall too low.

Your dose may be increased gradually up to 40 mg per day (given as two doses of 20 mg). A dose of between 10 mg and 20 mg per day given divided as two daily doses is usually enough to treat your condition.

You may be given your dose as one daily dose if you have mild to moderate heart failure and your condition has been stable on a daily dose of 20 mg divided in 2 doses for at least a month.

Your doctor will monitor your condition during the first two weeks of treatment and whenever you change your dose of Kinoprilam or diuretic.

If you suffer from kidney disease

Your starting dose of Kinoprilam should be reduced. Your dose of Kinoprilam depends on how well your kidneys work and will be decided by your doctor.

If Kinoprilam has not reduced your blood pressure after 3 months, your doctor may change your treatment.

If you are over 65 years of age

Your treatment should start at a dose of 5 mg once daily.

If you take more Kinoprilam than you should

Tell your doctor or pharmacist straight away or telephone casualty department. Remember to take the pack and any remaining tablets with you.

If you forget to take Kinoprilam

Do not worry. Simply leave out that dose completely and then take your next dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Kinoprilam

Do not stop taking Kinoprilam without first talking to your doctor.

If you have any further questions on the use of this medicine, 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 the medicine and contact your doctorimmediately if you get:

• chest pain or an assumed heart attack

• a severe skin reaction

• unexplained fever, flu-like symptoms such as sore throat (these symptoms can advert to a decreased white blood cell count)

• yellow discolouration of the eye whites or skin, which can be a symptom of an inflammation of the liver (hepatitis).

Kinoprilam can cause the following side effects:

Please consult your doctor in regular intervals as requested. This will help to detect possible side effects. Please inform your doctor during the routine examination, if you experience or experienced a possible side effect.

Common (may affect up to 1 in 10 people):

• dizziness

• low blood pressure (hypotension)

• cough

• feeling sick (nausea)

• being sick (vomiting)

• loose stools (diarrhoea)

• headache

• tiredness (fatigue)

• excessive potassium in blood (hyperkalaemia)

• sleep disorders (insomnia)

• abnormal sensations (paraesthesia)

• shortness of breath (dyspnoea)

• indigestion (dyspepsia)

• abdominal (tummy) pain

• back pain

• muscle pain

• weakness (asthenia)

• chest pain

• stuffy and runny nose (rhinitis)

• sore throat (pharyngitis)

• increases in creatinine and urea (waste products) especially when Kinoprilam is used with diuretic medicines

Uncommon (may affect up to 1 in 100 people):

• nervousness

• feeling sad (depression)

• confusion

• sleepiness

• weakness of arms, legs or problems speaking which may be symptoms of a minor stroke (transient ischaemic attack)

• impaired vision (amblyopia)

• sounds in the ear (tinnitus)

• feeling of spinning or rotation of surroundings (vertigo)

• temporary loss of consciousness due to lack of blood in the brain (syncope)

• abnormal heartbeat (palpitations)

• angina pectoris

• rapid heart rate (tachycardia)

• cardiac arrest (asystolia)

• heart attack (myocardial infarction). When the blood supply to part of the heart is interrupted.

• widening of the blood vessels (vasodilation)

• dry throat

• dry mouth

• flatulence (wind)

• swelling of the face, lips, throat and/or tongue (angioedema)

• skin rash (exanthema)

• itch

• excessive sweating

• impotence

• impaired kidney function

• presence of an excess of serum proteins in the urine (proteinuria)

• swelling (generalised or peripheral oedema)

• fever

• inflammation of the airways in the lungs (bronchitis)

• upper respiratory tract infection

• urinary tract infection

• inflammation of the sinuses (sinusitis)

Rare (may affect up to 1 in 1,000 people):

• neuropathy (abnormal nerve function, causing symptoms such as pain, numbness and abnormal sensation)

• balance disorder

• blurred vision

• worsening of asthma

• pneumonia

• altered taste

• constipation

• inflammation of the tongue (glossitis) disturbances in liver function

• skin disorder due to an allergic reaction or infection (erythema multiforme)

• pemphigus (a skin disease with blistering and sores)

• psoriasis-like rashes (red scaly patches on the skin)

• joint pain

Very rare (may affect up to 1 in 10,000 people):

• swelling of the wall of the bowels (small bowel angioedema)

• obstructed bowel (ileus)

Not known (frequency cannot be estimated from the available data):

• extremely low numbers of white blood cells (neutropenia/agranulocytosis)

• a low level of platelets in the blood (thrombocytopenia)

• reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia)

• severe allergic (anaphylactoid) reaction to this medicine

• intense skin rash including hives, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson syndrome, toxic epidermal necrolysis)

• inflamed, flaky skin (exfoliative dermatitis),

• hair loss,

• skin sensitivity to sunlight

• skin disorders may be associated with fever, inflammation of the membranes, blood vessel inflammation, muscle pain, joint pain, that can also influence blood test results

• stroke (cerebrovascular accident).

• orthostatic hypotension (feeling faint, particularly when standing)

• narrowing of the airways in the lungs (bronchospasm). In individual cases, upper airways obstruction by angioedema (that may be fatal).

• inflammation of the pancreas

• liver inflammation (hepatitis)

• yellowing of the skin or the eyes (jaundice) reduction in haemoglobin (a blood protein) levels

• reduction in the number of red blood cells

• increased liver enzymes

• increased blood bilirubin

Some ACE inhibitors cause:

• breast growth in men

• inflamed blood vessels

This might also happen with Kinoprilam.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kinoprilam

Keep this medicine out of the sight and reach of children.

Do not store above 30 °C.

Do not use this medicine after the expiry date, which is stated on the pack. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other Information

What Kinoprilam contains

The active substance is quinapril.

Each 5 mg film-coated tablet contains 5 mg quinapril (as quinapril hydrochloride).

Each 10 mg film-coated tablet contains 10 mg quinapril (as quinapril hydrochloride).

Each 20 mg film-coated tablet contains 20 mg quinapril (as quinapril hydrochloride).

Each 40 mg film-coated tablet contains 40 mg quinapril (as quinapril hydrochloride).

The other ingredients in the tablet core are:

Heavy magnesium carbonate

Anhydrous calcium hydrogen phosphate

Pregelatinised starch

Croscarmellose sodium

Magnesium stearate

The other ingredients in the film coating are:

Hypromellose

Hydroxypropylcellulose

Titanium dioxide (E171)

Macrogol 400

Red iron oxide (E172)

What Kinoprilam 5 mg, 10 mg, 20 mg, 40 mg film-coated tablets look like and the content of the pack

Kinoprilam 5 mg film-coated tablets are oval, biconvex, red-brown, scored on both sides and imprinted with "I" on one side. Size 4.5 x 8.7 mm.

Kinoprilam 10 mg film-coated tablets are oval, biconvex, red-brown, scored on both sides and imprinted with "L" on one side. Size 5.8 x 11.3 mm.

Kinoprilam 20 mg film-coated tablets are round, biconvex, red-brown, scored on both sides and imprinted with "I" on one side. Diameter 7 mm.

Kinoprilam 40 mg film-coated tablets are oval, biconvex, red-brown, scored on both sides and imprinted with "I" on one side. Size 6.5 x 12.7 mm.

Kinoprilam tablets can be divided into equal halves.

Kinoprilam tablets are available as:

• blister strips (Al/Al) containing 10, 14, 28, 30, 50, 56, 98, 100 and 500 (5 x 100) tablets

• plastic (polypropylene) container containing 250 tablets and a substance to keep them dry (desiccant).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

Tel.

Fax:

E-mail:

http://www.

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in 13 Nov 2014