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PACKAGE LEAFLET: INFORMATION FOR THE USER

Kipristad 5 mg, 10 mg, 20 mg film-coated tablets

Active substance: quinapril

Read all of this leaflet carefully before you start using this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Kipristad is and what it is used for

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

Kipristad 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.

Kipristad is used to

• treat high blood pressure

• treat congestive heart failure (when the heart cannot pump enough blood around the body). Kipristad is used to treat congestive heart failure together with water tablets and - especially in severe heart failure - also in addition to digitalis a heart medicine; also called digoxin),

2. Before you use Kipristad

DO NOT use Kipristad

• If you are allergic (hypersensitive) to quinapril or to any of the other ingredients of Kipristad

• If you are allergic (hypersensitive) to any other ACE inhibitor

• If you 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.

• If you suffer from hereditary or unexplained angioedema

• If you are more than 3 months pregnant. (It is also better to avoid Kipristad 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).

Take special care with Kipristad

You must tell your doctor if you think you are (or might become)pregnant. Kipristad 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 tellyour 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)

• 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 youare being given one of the following treatments:

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

• Kidney transplant

• Other types of surgery or anaesthesia

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

• 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)

Symptomatic low blood pressure

In some cases Kipristad 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 diarrohea 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, Kipristad 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.

Using other medicines

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

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: Kipristad 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): Kipristad 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 Kipristad on your blood pressure. When Kipristad is used to treat chronic heart failure, it is likely that it will reduce the effects of furosemide (a loop diuretic).

• • Non-steroidal anti-inflammatory drugs (rheumatism drugs): These may decrease the activity of Kipristad. 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 Kipristad.

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

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

  • 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 Kipristad 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).

  • Antacids. Antacids reduce the effect of Kipristad.

  • 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.

Taking Kipristad with food and drink

Kipristadcan be taken with or without food.

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

Pregnancy and breast-feeding

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 Kipristad before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Kipristad. Kipristad 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 Kipristad.

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

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

Driving and using machines

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

3. How to use Kipristad

Always use Kipristad exactly as your doctor has told you. You should 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.

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

Children and adolescents:

Kipristad is not recommended for use in children and adolescents.

Adults:

If you take Kipristad only (monotherapy)

The dose may be adjusted, depending on your response. Dose adjustment should be at 3-week intervals.Kipristad is taken once daily, although some patients may take it twice daily.

	Amount [mg]	Kipristad film-coated tablets
		5 mg [daily no. of tablets]	10 mg [daily no. of tablets]	20 mg [daily no. of tablets]
Starting dose	10	2	1	½
Maintenance dose	10-20	2-4	1-2	½-1
Maximum dose	40	8	4	2

* This strength cannot be used.
^# This strength cannot be used in the lower range.

If you take Kipristad in combination with diuretics (combination therapy)

The first dose is 2.5mg. The dose should then be adjusted by your doctor until the best response is achieved.

If you take Kipristad for heart failure

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

You may begin treatment as an outpatient. However, if you have severe heart failure or your kidneys are not working well, you should be given Kipristad in hospital.

The first dose is 5 mg Kipristad (taken as 2.5 mg twice a day). After this dose your doctor will monitor your blood pressure to make sure it does not fall too low.

Depending on how well you respond to therapy, your dose may be increased stepwise. A dose of between 10 mg and 20 mg per day is usually enough to treat your condition.

You should not take more than 40 mg per day (20 mg twice a day).

Your doctor will monitor your condition:

• during the first two weeks of treatment

• whenever you change your dose of Kipristad or diuretic

If you have not responded well to treatment after 3 months, your doctor may change your treatment.

If you suffer from kidney disease or are over 65 years of age:

The starting dose of Kipristad should be reduced in patients with kidney disease or in elderly patients. Your dose of Kipristad depends on how well your kidneys work and will be decided by your doctor.

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

If you take more Kipristad 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 Kipristad

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

If you stop taking Kipristad

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

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

4. Possible side effects

Like all medicines, Kipristad can cause side effects, although not everybody gets them. Evaluation of the side effects is based on the following frequencies:

Very common:	In more than 1 in 10 patients treated
Common:	In less than 1 in 10, but more than 1 in 100 patients treated
Uncommon:	In less than 1 in 100, but more than 1 in 1,000 patients treated
Rare:	In less than 1 in 1,000, but more than 1 in 10,000 patients treated
Very rare:	In less than 1 in 10,000 patients treated, including isolated cases
Not known:	Cannot be estimated from the available data

Stop taking the medicine and contact your doctor immediately if you get:

Kipristadcan 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:

• nervousness

• difficulty sleeping (insomnia)

• tiredness (fatigue)

• drowsiness

• depressed mood

• dizziness

• disturbances in balance

• sleep disorders, sleepiness

• low blood pressure (hypotension)

• shortness of breath (dyspnoea)

• nausea

• vomiting

• diarrhoea

• exanthema (an eruption of rash)

• headache

• chest pain

• abnormal sensations (paraesthesia)

• indigestion (dyspepsia)

• weakness (asthenia)

• stuffy and runny nose (rhinitis)

• sore throat (pharyngitis)

• muscle pain

• back pain

• excessive potassium in blood (hyperkalaemia)

• increases in creatinine and urea (waste products) especially when Kipristad is used with diuretics

Uncommon:

• abnormal heartbeat (palpitations)

• angina pectoris (chest pain)

• rapid heart rate (tachycardia)

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

• widening of the blood vessels (vasodilation)

• loss of appetite

• dry mouth

• flatulence (wind)

• digestive disturbances

• itch

• pemphigus (form of skin eruption)

• inflamed, flaky skin (exfoliative dermatitis)

• excessive sweating

• hair loss

• skin sensitivity to sunlight

• depression

• confusion

• impaired vision (amblyopia)

• sounds in the ear (tinnitus)

• feeling of spinning or rotation of surroundings (vertigo)

• impaired kidney function

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

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

If you are black you are more likely to develop such swellings.

• heart attack

• dry throat

• inflammation of the airways in the lungs (bronchitis)

• upper respiratory tract infection

• urinary tract infection

• inflammation of the sinuses (sinusitis)

• impotence

• fever

• swelling (generalised and peripheral oedema)

Rare:

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

• vision blurred

• worsening of asthma,

• pneumonia

• altered taste

• constipation

• inflammation of the tongue (glosstitis)

• disturbances in liver function

• joint pain

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

• erythema multiforme (an inflammatory skin condition)

Very rare:

• disturbances in heart rhythm

• attacks of poor circulation in the fingers or toes (Raynaud’s phenomenon)

• blockage in the gut (ileus)

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

• psoriasis (a skin disease)

• loosening of nails

Not known:

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

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

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

• 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)

• 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.

• inflammation of the pancreas

• stroke (cerebrovascular accident)

• liver inflammation (hepatitis)

• yellowing of the skin or the eyes (jaundice)

• 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).

• 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 Kipristad.

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 {to be completed nationally: 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 Kipristad

Keep out of the reach and sight of children.

Do not store above 25 °C.

Do not use Kipristad after the expiry date, which is stated on the pack. The expiry date refers to the last day of that 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. Further Information

What Kipristad 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).

The other ingredients in the tablet core are:

Heavy magnesium carbonate

Anhydrous calcium hydrogen phosphate

Pregelatinised maize 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 Kipristad 5 mg, 10 mg, 20 mgfilm-coated tablets look like and the content of the pack

Kipristad 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.

Kipristad 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.

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

Kipristad tablets can be divided into equal halves.

Kipristad tablets are available as:

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

• plastic container containing 250 tablets

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 approved in 2014-09-15