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Kinoprilam

Information för alternativet: Kinoprilam 20 Mg Filmdragerad Tablett, visa andra alternativ

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.


What is in this leaflet

What Kinoprilam is and what it is used for

What you need to know before you use Kinoprilam

How to use Kinoprilam

Possible side effects

How to store Kinoprilam

Contents of the pack and other information


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:


2. What you need to know before you use Kinoprilam


DO NOT use Kinoprilam if you:


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:

certain heart diseases, e.g.


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

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


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:


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.



Amount
[mg]

Kinoprilam film-coated tablets

5 mg
[daily no. of tablets]

10 mg
[daily no. of tablets]

20 mg
[daily no. of tablets]

40 mg
[daily no. of tablets]

Starting dose

10

2

1

½

-*

Maintenance dose

20-40

4-8

2-4

1-2

½-1

Maximum dose

40

8

4

2

1

* 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:

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:

symptoms of angioedema (a life-threatening reaction), such as:

  • swollen face, tongue or throat

  • difficulty in swallowing

  • hives and difficulty breathing


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):


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):


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


Some ACE inhibitors cause:


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:


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


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