Package leaflet: Information for the user

Kipristad comp 10 mg/12.5 mg, 20 mg/12.5 mg
and 20 mg/25 mg film-coated tablet

Quinapriland hydrochlorothiazide

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 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.

What is in this leaflet

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

2. What you need to know before you take Kipristad comp

3. How to take Kipristad comp

4. Possible side effects

5. How to store Kipristad comp

6. Contents of the pack and other information

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

Kipristadcomp contains two active substances (substances that can improve your symptoms):

• Quinapril

• Hydrochlorothiazide

Quinapril belongs to a group of medicines that are known as antihypertensives. Antihypertensives are medicines that are used to treat high blood pressure.

Quinapril 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. Angiotensin tightens blood vessels. By blocking angiotensin the blood vessels are able to relax, which in turn lowers blood pressure.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. Diuretics are also known as water tablets. These cause you to produce more urine. This helps to lower your blood pressure.

The two active substances in Kipristad comp work together to lower your blood pressure. They work better together than either would work alone.

Kipristad comp is used to:

2. What you need to know before you take Kipristad comp

DO NOT take Kipristad comp

• quinapril hydrochloride

• any other ACE inhibitor (e.g. enalapril, ramipril, lisinopril)

• hydrochlorothiazide

• medicines containing sulphonamide

• any of the other ingredients of this medicine listed in section 6)

• if you have developed severe allergic reactions after previous treatment with an ACE inhibitor. Such reactions lead to swelling of the face, hands or feet, lips, tongue or throat - which can cause shortness of breath or difficulty in swallowing (angiooedema).

• if you suffer from hereditary or unexplained swelling of the skin (angiooedema).

• if you have severe kidney disease or are experiencing problems passing water (anuria).

• if you have severe liver disease.

• if you are more than 3 months pregnant. (It is also better to avoid Kipristad comp in early pregnancy - see section “Pregnancy and breast-feeding”).

• if you have an obstruction in your heart that slows blood in the heart.

Warnings and precautions

Talk to your doctor or pharmacist before takingKipristad comp

ifyou are suffering from any of the following illnesses:

• Mild to moderate kidney disease. Your doctor may adjust your dose, as Kipristad comp may be harmful to you if you have an impaired kidney function.

• Narrowing of the blood vessels supplying the kidneys (renal artery stenosis).

• Narrowing of the blood vessels from the heart (valve stenosis).

• Obstructive hypertrophic cardiomyopathy. This is a thickening of the heart muscle which causes blockage of the flow of blood out of the heart.

• Ischaemic heart disease (when the blood supply to the heart is limited).

• Low blood pressure.

• Ischaemic cerebrovascular disease (when the blood supply to the brain is limited).

• Severe renin-dependent high blood pressure (a special type of high blood pressure).

• If your liver is not working properly.

• If you have an imbalance of body salts (electrolytes) and fluids. This includes particularly:

• An abnormally low volume of body fluid

• Low levels of sodium, potassium, magnesium and chloride, or high levels of potassium and calcium in the blood

• If you have an imbalance of electrolytes or fluids, your doctor will correct this before you start treatment This might happen if you have been vomiting a lot, or if you have had persistent diarrhoea. Other signs of an imbalance include dryness of the mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, low blood pressure, decreased urine production and rapid heart beat.

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

• Gout (a disorder which causes very painful inflamed joints).

• Diabetes (raised blood sugar levels).

• Severe heart failure (heart failure that requires close control by your doctor). If you have heart failure, your doctor will tell you whether you can take this medicine.

• If you develop a persistent dry cough.

• Collagen disease (systemic autoimmune disease such as lupus erythematosus). In systemic autoimmune diseases the immune system attacks many different organs, tissues, and cells of the body. Severe allergic reactions leading to swelling of the skin (angioedema) or inside your mouth.

• A rapid swelling of the wall of the bowels (intestines) can occur when taking Kipristad comp. Patients can experience abdominal pain with or without vomiting.

• You should seek immediate medical attention if you experience a sudden misty vision and loss of vision or intense pain in the eye. These are symptoms of an unusual reaction resulting in visual disturbances and increased pressure in the eye caused by one of the active ingredients, hydrochlorothiazide. If this is not treated, it can lead to permanent loss of vision.

if you are being given one of the following treatments:

• Kidney transplant.

• Haemodialysis (when your blood is cleaned using a dialysis machine).

• Tests for parathyroid gland function.

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

• Immunosuppressant therapy (medicines used to suppress your body’s immune system e.g. ciclosporin). These medicines are used to help prevent rejection of an organ transplant).

• Desensitisation therapy (to reduce the effects of an allergy, e.g. wasp stings).

• Potassium supplements (vitamins and minerals containing potassium) or potassium containing table salt substitutes.

• Potassium-sparing diuretics (medicine which increase the amount of water you pass in your urine).

• Any medicine that might cause an increase in serum potassium (such as heparin).

• Lithium (a medicine used for mental disorders) (see also section “Other medicines and Kipristad comp”).

Tell your doctor immediately if you experience the following symptoms:

• Swelling of face, limbs, lips, mucous membranes, tongue and/or larynx, difficulty in swallowing and breathing.

• Yellow discoloration of skin and mucous membranes.

• Fever, swelling of the lymph nodes and/or inflammation of the throat.

• A severe skin reaction (e.g. a blistering or scaling rash) during treatment with Kipristad comp.

In these cases, you must stop taking Kipristad compand your doctor will take appropriate measures.

Symptomatic low blood pressure

In some cases Kipristad comp may cause your blood pressure to drop too low. This is more likely to occur if you have any of the conditions listed above. In this case your doctor will take action to increase your blood pressure to a safe level.

Ethnic differences

If you are black, Kipristad comp may be less effective in lowering your blood pressureor you might be more likely to suffer serious side effects (e.g. angiooedema).

Surgery

Before surgical treatments and narcosis (this also applies to dental treatment) your doctor/dentist should be aware that you are being treated with Kipristad comp as there is a risk that your blood pressure may decrease dramatically during the anaesthetic.

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Kipristad comp 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 section “Pregnancy and breast-feeding”).

<To be completed nationally>

According to the CMD(h) discussion in June 2008 each member state should decide whether or not to include the doping warning in the national text

Anti-doping tests

Kipristad comp may produce a positive result in an anti-doping test.

Children and adolescents

Kipristad comp should not be used by children or adolescents.

Othermedicines and Kipristad comp

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

The effect of Kipristad comp can be affected by or can affect the following medicines:

• tetracyclines, trimethoprim (antibiotics)

• medicines which lead to increases in the level of potassium in the blood:

• blood thinning medicines (e.g. heparin)

• potassium supplements or salt substitutes containing potassium

• diuretic medicines (water tablets, e.g. furosemide, thiazide diuretics, amiloride, spironolactone, triamterene and sulphonamide)

• antihypertensives (used to treat high blood pressure, e.g. beta-blockers or ACE-inhibitors)

• nitrates (used for angina, e.g. glyceryl trinitrate)

• vasodilators (medicines which relax the blood vessels)

• lithium (to treat psychiatric disorders such as bipolar disorder)

• tricyclic antidepressants (to treat depression e.g. amitriptyline, trimipramine)

• anaesthetics (e.g. barbiturates such as phenobarbital)

• antipsychotics to treat mental diseases (e.g. phenothiazines such as chlorpromazine, thioridazine)

• narcotics (strong pain-killers)

• non-steroidal anti-inflammatory drugs (NSAIDs e.g. indomethacin, ibuprofen including 3 grammes or more of acetylsalicylic acid per day)

• sympathomimetics (medicines with similar effects as those from the sympathic nervous system, including e.g. adrenaline, noradrenaline and dopamine)

• insulin (for diabetes), oral antidiabetic medicines (medicines taken by mouth to control the level of sugar in the blood)

• antacids (medicines used for indigestion)

• amphotericin B (for fungal infections)

• carbenoxolone, glucocorticoids (anti-inflammatory medicines, steroids for example hydrocortisone, dexamethasone or prednisolone)

• adrenocorticotropic hormone (ACTH, a steroid stimulating hormone)

• laxatives (to increase bowel movement)

• calcium salts

• cardiac glycosides (used to treat heart disease, e.g. digoxin)

• cholestyramine or colestipol (used to lower the level of cholesterol in the blood)

• curare-type muscle relaxants (e.g. tubocurarine chloride) medicines used during surgical operations

• medicines which may influence the heart rhythm (prolongation of the so called QT interval in the ECG) and may lead to certain arrhythmias including antiarrhythmics to treat heart rhythm disorders.

• procainamide (used to correct irregular heartbeats), cytostatic drugs (cancer therapy), immunosuppressants (for the treatment of autoimmune diseases such as Crohn’s disease and rheumatoid arthritis), allopurinol (for the treatment of chronic gout)

Kipristad comp with food,drink and alcohol

Kipristad comp can be taken with or without food.

You should not drink alcohol as this may increase the effect of Kipristad comp 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, askyour doctor or pharmacist for advice before taking thismedicine.

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Kipristad comp before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Kipristad comp. Kipristad comp is not recommended during 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 month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Kipristad comp is not recommended for mothers who are breast-feeding.

Driving and using machines

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

3. How to take Kipristad comp

Always take this medicineexactly 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 equal doses.

You should swallow the tablets or tablet halves whole, not chewed, with a glass of water. You may take the tablets before, during or after a meal. Please avoid an extremely high fat content in the food, as this may reduce the uptake of quinapril hydrochloride if taken at the same time as Kipristad comp.

Recommendeddosage

You should take Kipristad comp once daily in the morning.

Treatment of essential hypertension

You should not take Kipristad comp as your first treatment for essential hypertension (see Section 1). To start with, your doctor will usually give you the two medicines (quinapril and hydrochlorothiazide) separately. This will allow him to decide what dose you need. He will then tell you to switch to treatment with Kipristad comp.

Kipristad comp 10 mg/12.5 mg tablets may be divided into two halves. Each half will contain 5 mg quinapril and 6.25 mg hydrochlorothiazide.

Kipristad comp 20 mg/12.5 mg tablets may be divided into two halves. Each half will contain 10 mg quinapril and 6.25 mg hydrochlorothiazide.

Kipristad comp 20 mg/25 mg tablets may be divided into two halves. Each half will contain 10 mg quinapril and 12.5 mg hydrochlorothiazide.

If you have an impaired kidney function, your doctor may prescribe you a lower dose. In case of a severely impaired kidney function (creatinine clearance < 30 ml/min), you must not take Kipristad comp (see also section 2 “DO NOT take Kipristad comp”).

If you are elderly you should use Kipristad comp with caution. Your doctor will prescribe the lowest effective dose.

Children and adolescents should not use Kipristad comp (see section 2. “What you need to know beforeyou take Kipristad comp”).

Duration of treatment

Your doctor will tell you for how long you should take Kipristad comp.

If you take more Kipristad comp than you should

Contact your doctor or go to your nearest hospital immediately:

• If you have taken too many tablets

• If you suspect an overdose(e.g. if you feel ill after taking too many tablets)

Remember to take the pack and any remaining tablets with you to the doctor.

You may experience the following symptoms of overdose:

• increased urine production (diuresis)

• electrolyte imbalance (imbalance of body salts)

• very low blood pressure (severe hypotension)

• lowered consciousness, including coma (a state of unconsciousness from which you cannot be awoken)

• convulsions (fits)

• loss of movement (paresis)

• irregular heartbeat (arrhythmia) including slower heart beat (bradycardia)

• kidney failure

Your doctor will treat the symptoms of overdose. He may also ask you to take activated charcoal. This is a substance that will stop your bowel from absorbing more of the medicine. He may also ask you to take sodium sulphate. This is a laxative substance that speeds up the emptying of your digestive system.

If you forget to take Kipristad comp

Do not take a double dose to make up for a forgotten tablet. Just take your normal dose when it is due.

If you stop taking Kipristad comp

Do not stop taking your Kipristad comp unless your doctor tells you to. If you stop taking your tablets suddenly your symptoms may get worse. Your doctor will tell you how to reduce and then stop this medicine.

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.

If you suffer from any of the following symptoms, stop taking Kipristad comp and contact your doctor or go to your nearest emergency departmentimmediately:

• swelling of the skin, of the face and lips or voice box

• swelling of the tongue and throat causing difficulty breathing or swallowing

If you are black you are more likely to suffer angiooedema.

• severe abdominal pain causing you to be sick (intestinal angiooedema)

• heart attack (myocardial infarction), symptoms may include chest pain, tightness of the chest, shortness of breath or trouble breathing

• weakness of arms, legs or problems speaking which may be symptoms of a possible stroke (cerebrovascular accident)

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

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

• tiredness (fatigue), difficulty in sleeping (insomnia), sleepiness (somnolence)

• feeling of weakness (asthenia)

• dizziness

• cough, bronchitis

• nose or throat infections (upper respiratory tract infections, pharyngitis), runny, itchy nose (rhinitis)

• feeling sick (nausea), being sick (vomiting), diarrhoea, indigestion (dyspepsia)

• headache

• abdominal pain, back pain, muscle pain (myalgia)

• chest pain, feeling of tightness and pain in the chest (angina pectoris)

• abnormally high concentration of uric acid in the blood (hyperuricaemia)

• abnormally high concentration of potassium in the blood (hyperkalaemia)

• increases of creatinine and urea in the blood (these are indicators of kidney function)

• high levels of uric acid in the blood causing swollen, painful joints (gout)

• faster heart beat (tachycardia), feeling the heart beating in the chest (palpitations)

• relaxation of the blood vessels (vasodilatation)

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

• impaired glucose tolerance

• low blood pressure (hypotension)

• nervousness

• abnormal feelings in the skin, like pins and needles, itching or tingling (pruritus, paraesthesia), rash, sensitivity to sunlight (photosensitivity)

• fainting (syncope), a feeling of dizziness or “spinning” (vertigo)

• mini stroke (transient ischaemic attack or TIA), a brief attack (from a few minutes to an hour) of cerebral dysfunction of vascular origin, with no persistent neurological deficit

• excessive wind (flatulence), altered taste (dysgeusia)

• dryness of the mouth

• excessive sweating (hyperhidrosis)

• hair loss (alopecia)

• erectile dysfunction

• viral infection, urinary tract infection

• inflammation of your sinuses (sinusitis)

• fever (pyrexia)

• confusion

• depression

• lazy eye (amblyopia)

• ringing in the ears (tinnitus)

• shortness of breath (dyspnoea)

• dry throat

• fluid retention in the body (generalised oedema), swelling of the ankles, feet or fingers (peripheral oedema)

• pain in joints (arthralgia)

• impaired kidney function

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

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

• swelling of the skin, of the face and lips or voice box, swelling of the tongue and throat causing difficulty breathing or swallowing (upper airways obstruction by angiooedema)

• inflammation of the lungs which can cause breathlessness, cough and raised temperature (eosinophilic pneumonia)

• disturbances of balance

• skin disorders may be associated with: fever, inflamed blood vessels (vasculitis), muscle pain (myalgia), joint pain, inflammation (arthralgia/arthritis), variety of inflammatory skin disorders (dermatitis psoriasiforms) and change in several laboratory values

• constipation

• inflammation of the tongue (glossitis)

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

• hives (urticaria)

• temporary blurring of vision

• decreased movements of the bowel (ileus)

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

• purple or red pinpoint spots in the skin or mucous membranes caused by minor haemorrhage (purpura)

• red blotchy skin rash (erythema multiforme)

• inflamed and scaling skin (dermatitis exfoliative)

• blistering of the skin (pemphigus), severe, even life-threatening skin reaction (toxic epidermal necrolysis)

• allergic condition which causes joint pain, skin rashes and fever (systemic lupus erythematosus)

• inflamed body tissues (serositis)

• abnormal increase in eosinophils (a certain type of white blood cells)

• slight reduction in the number of red cells in the blood (haematocrit decreased)

• increased amounts of liver enzymes in the blood

• increased amounts of bilirubin in the blood

• increased amounts of antinuclear antibody (ANA) in the blood

• increases in cholesterol and triglycerides (types of fats) in the blood

• inflammation of the kidneys (interstitial nephritis)

• inflamed liver (hepatitis)

• yellowing of the skin and of the whites of the eyes (jaundice, caused by blockage of the flow of bile)

• inflamed pancreas (pancreatitis)

• tightening (constriction) of the lower airways (bronchospasm)

• a fall in blood pressure on standing up which causes dizziness, lightheadedness or fainting (orthostatic hypotension)

• irregular heart beat (arrhythmia)

• allergic (anaphylactic) reactions

• reduced number of white cells in the blood (neutropenia)

• severe low number of white blood cells which makes infections more likely (agranulocytosis)

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

• reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)

• red blood cell sedimentation rate increased (non-specific measure of inflammation)

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 comp

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

Store below 30°C.

Store in the original package.

Do not use this medicineafter the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Donot 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 otherinformation

What Kipristad comp contains

The active substances are:

• quinapril (as quinapril hydrochloride)

• hydrochlorothiazide

One Kipristad comp 10 mg/12.5 mg film-coated tablet contains 10 mg quinapril and 12.5 mg hydrochlorothiazide.

One Kipristad comp 20 mg/12.5 mg film-coated tablet contains 20 mg quinapril and 12.5 mg hydrochlorothiazide.

One Kipristad comp 20 mg/25 mg film-coated tablet contains 20 mg quinapril and 25 mg hydrochlorothiazide.

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:

• Hydroxypropylcellulose

• Hypromellose

• Titanium dioxide (E171)

• Macrogol 400

• Yellow iron oxide (E172)

• Red iron oxide (E172)

What Kipristad comp film-coated tablets look like and contents of the pack

Kipristad comp 10 mg/12.5 mg film-coated tablets are oval, pink, and biconvex in shape. They have a break-line on both sides and are imprinted with "I" on one side. They are 4.5 x 8.7 mm.

Kipristad comp 20 mg/12.5 mg film-coated tablets are oval, pink, and biconvex in shape. They have a break-line on both sides and are imprinted with "I" on one side. They are 5.8 x 11.3 mm.

Kipristad comp 20 mg/25 mg film-coated tablets are round, pink, and biconvex in shape. They have a break-line on both sides and are imprinted with "I" on one side. They are 8.5 mm in diameter.

Kipristad comp film-coated tablets are available as:

• aluminium/polyamide/PVC blister packs containing 10, 14, 20, 28, 30, 42, 50, 56, 98, 100 and 500 (5x100) tablets

• a polypropylene tablet container containing 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

To be completed nationally

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

This leaflet was last revisedin 2014-09-15.