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Kinastad Comp


Package leaflet: Information for the user


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

Quinapril and hydrochlorothiazide


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


What is in this leaflet

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

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

3. How to take Kinastad comp

4. Possible side effects

5. How to store Kinastad comp

6. Contents of the pack and other information


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


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


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 Kinastad comp work together to lower your blood pressure. They work better together than either would work alone.


Kinastad comp is used to:

treat essential hypertension (high blood pressure with no specific medical cause). You should not use Kinastad comp as your first treatment for essential hypertension. You should use Kinastad comp when previous treatment with quinapril alone has not worked well enough.


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


DO NOT take Kinastad comp

if you are allergic to


Warnings and precautions

Talk to your doctor or pharmacist before taking Kinastad comp


if you are suffering from any of the following illnesses:


if you are being given one of the following treatments:


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 Kinastad comp”


Tell your doctor immediately if you experience the following symptoms:


In these cases, you must stop taking Kinastad comp and your doctor will take appropriate measures.


Symptomatic low blood pressure

In some cases Kinastad 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, Kinastad comp may be less effective in lowering your blood pressure or 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 Kinastad 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 that you are (or might become) pregnant. Kinastad 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

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


Children and adolescents

Kinastad comp should not be used by children or adolescents.


Other medicines and Kinastad comp

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


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


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 Kinastad comp” and “Warnings and precautions”)


Kinastad comp with food, drink and alcohol

Kinastad comp can be taken with or without food.

You should not drink alcohol as this may increase the effect of Kinastad 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, ask your doctor or pharmacist for advice before taking this medicine.


Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Kinastad comp before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Kinastad comp. Kinastad 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. Kinastad comp is not recommended for mothers who are breast-feeding.


Driving and using machines

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


3. How to take Kinastad comp


Always take 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 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 Kinastad comp.


Recommended dosage


You should take Kinastad comp once daily in the morning.


Treatment of essential hypertension

You should not take Kinastad 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 Kinastad comp.


Kinastad 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.


Kinastad 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.


Kinastad 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 Kinastad comp (see also section 2 “DO NOT take Kinastad comp”).


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


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


Duration of treatment


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


If you take more Kinastad comp than you should

Contact your doctor or go to your nearest hospital immediately:


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


You may experience the following symptoms of overdose:


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 Kinastad 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 Kinastad comp

Do not stop taking your Kinastad 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 Kinastad comp and contact your doctor or go to your nearest emergency department immediately:

symptoms of an allergic (hypersensitivity) reaction (angioedema) such as:

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


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


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


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


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


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


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 Kinastad 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 medicine after the expiry date which is stated on the carton. 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 Kinastad comp contains

The active substances are:


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


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


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


The other ingredients in the tablet core are:


The other ingredients in the film coating are:


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

Kinastad 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.


Kinastad 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.


Kinastad 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.


Kinastad comp film-coated tablets are available as:


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


To be completed nationally


This leaflet was last revised in 13 Nov 2014


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