KERITRINA 5 mg /24 H Трансдермальный Пластырь

Содержание инструкции

1. Keritrina 5 mg/24 hour transdermal patches, 10 mg/24 hour transdermal patches, 15 mg/24 hour transdermal patches
   1. What is Keritrina and what is it used for
   2. What you need to know before using Keritrina
   3. How to use Keritrina
   4. Possible side effects
   5. How to store Keritrina
   6. Contents of the pack and other information

Keritrina 5 mg/24 hour transdermal patches, 10 mg/24 hour transdermal patches, 15 mg/24 hour transdermal patches

Nitroglycerin
Generic medicine

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Keritrina is and what it is used for
• 2. What you need to know before you use Keritrina
• 3. How to use Keritrina
• 4. Possible side effects
• 5. How to store Keritrina
• 6. Contents of the pack and other information

1. What is Keritrina and what is it used for

Keritrina is an adhesive patch that contains the active substance nitroglycerin, which is released into the body
through the skin. Nitroglycerin belongs to the group of medicines called nitrates which dilate the blood
vessels and make blood flow easier.
Keritrina is used for the treatment of angina pectoris, a painful constriction of the chest that occurs
when the heart muscles do not receive enough blood and oxygen.
Keritrina can be used for the treatment of angina pectoris alone or with other drugs belonging to the
class of beta-blockers and/or calcium channel blockers.
Keritrina 5 mg/24 hours is also used for

• preventing phlebitis (blockage of a vein, usually in the legs, that causes swelling);
• preventing extravasation (leakage of fluids from the veins) due to treatments administered intravenously that are expected to last 2 or more days.

2. What you need to know before using Keritrina

Do not use Keritrina

• if you are allergic to nitroglycerin, any organic nitrate or any of the other ingredients of this medicine (listed in section 6);
• if you have a severe form of circulatory system failure associated with a severe drop in blood pressure (shock);
• if you have a condition associated with: high pressure inside the head or cerebral haemorrhage or head trauma or high pressure inside the eye (closed-angle glaucoma)
• if you have severe anaemia;
• if you have heart failure due to: narrowing (stenosis) of the mitral valve; inflammation of the heart lining (constrictive pericarditis); obstruction to blood flow from the heart, such as in the case of narrowing (stenosis) of the aortic valve; disease with thickening of the heart walls (hypertrophic cardiomyopathy); fluid collection around the heart (pericardial tamponade);
• if you are taking medicines for erectile dysfunction (phosphodiesterase type 5 inhibitors) such as sildenafil (Viagra) as a severe drop in blood pressure may occur;
• if you suffer from very low blood pressure (systolic pressure less than 90 mmHg);
• if you have a low circulating blood volume (severe hypovolaemia);
• if you are taking a medicine containing the active substance riociguat used to treat high blood pressure in the lungs.

Warnings and precautions
Consult your doctor or pharmacist before using Keritrina if any of the following conditions apply to you:

• if you have recently had a heart attack or if you suffer from acute heart failure;
• if you suffer from hypoxaemia (reduced oxygen content of arterial blood) due to severe anaemia;
• if you suffer from hypoxaemia due to lung disease or severe heart disease (ischaemic heart failure);
• if you have thickening of the heart muscle (hypertrophic cardiomyopathy).

Take special care:

• and inform your doctor that you are using KERITRINA if you are to undergo procedures that use magnetic or electric fields such as magnetic resonance imaging (MRI), cardioversion or defibrillation (an electric shock used to restore the heart to its normal rhythm) or diathermy (production of heat in body tissues by irradiation to treat or relieve certain conditions), because the patch must be removed before these procedures;
• if you are using therapy intermittently, because during the periods when the transdermal patch is not applied, an increase in the frequency of angina attacks may occur. In these cases, the doctor will assess whether to give you another medicine;
• a loss of response (tolerance) to nitroglycerin patches may occur, if this occurs the effect of sublingual nitroglycerin may also be reduced;
• if your blood pressure becomes very low, consult your doctor who will tell you whether to continue using Keritrina or to remove the patch.

If you are using Keritrina to prevent phlebitis, your doctor will regularly check the infusion site.

Children and adolescents
Keritrina should not be used in paediatric patients.

Other medicines and Keritrina
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not use Keritrina together with

• medicines for erectile dysfunction (phosphodiesterase type 5 inhibitors) such as sildenafil (Viagra), as, when taken together with Keritrina, they can cause a severe drop in blood pressure;
• medicines containing the active substance riociguat, used to treat high blood pressure in the lungs;

Inform your doctor if you are using:

• calcium antagonists, beta-blockers, ACE inhibitors, antihypertensives, diuretics (medicines used to lower blood pressure, for fluid retention or for heart problems);
• tricyclic antidepressants and major tranquillizers (medicines for treating anxiety or depression);
• dihydroergotamine, used for example for migraine;
• amifostine (a medicine used to reduce the side effects of certain cancer treatments or radiotherapy);
• acetylsalicylic acid;
• non-steroidal anti-inflammatory drugs, NSAIDs (used to treat pain and inflammation).

Keritrina and alcohol
Do not drink alcohol when using Keritrina, as alcohol may enhance the lowering of blood pressure that can occur when using the patch.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
If you are pregnant, your doctor will assess whether the benefits for you clearly outweigh the risks to the fetus before prescribing Keritrina, especially during the first three months of pregnancy.

Breastfeeding
There is insufficient information on the passage of nitroglycerin into breast milk.
The doctor will decide whether to discontinue breastfeeding or stop therapy with Keritrina taking into account the benefit of breastfeeding for the baby and the benefit of therapy for the woman.

Fertility
No data are available regarding the effect of Keritrina on fertility in men.
There are no data to support special recommendations in women of childbearing potential.

Driving and operating machinery
Keritrina may alter your reactions or may rarely cause dizziness or low blood pressure when you stand up, especially at the beginning of treatment or when the dose is changed. If you experience these symptoms, do not drive and do not use machines.

3. How to use Keritrina

Use this medicine following exactly the instructions of your doctor. If you have doubts, consult your doctor.
The response to Keritrina varies from patient to patient; therefore, you should use the dose prescribed by your doctor.

Treatment of angina pectoris
Keritrina is used to prevent angina and not to treat a sudden attack. In case of a sudden
attack of angina, you should use another medicine prescribed by your doctor.
The normally recommended initial dose is 1 Keritrina 5 mg/24 hour patch per day.
For maintenance therapy, your doctor will prescribe 1 Keritrina 10 mg/24 hour patch (normal maintenance dose) or 1 Keritrina 15 mg/24 hour patch.

Prevention of phlebitis and extravenous suffusion
Your doctor will apply a Keritrina 5 mg/24 hour patch to a point distant from the vein into which the
cannula is inserted, at the same time the cannula is inserted.
It is advisable to replace the patch daily. Treatment with Keritrina should be discontinued at the end
of the therapy administered into the vein.
Prolonged or frequent administration of long-acting nitrates, including Keritrina or other
transdermal patches, may cause a loss of response (tolerance) or a reduction in the effectiveness of
therapy.
The effectiveness of therapy can be maintained by removing the patch for 8-12 hours each day, generally
at night.
Apply the patch to a clean, dry, and undamaged area of skin on the chest or arms, without
hair or residues of ointments or creams.
The patch can be applied either continuously for 24 hours, or intermittently, removing it for a few
hours, usually during sleep.
After the use prescribed by your doctor, remove the patch and discard it, apply a new patch to a
different area.
For good adhesion of the patch to the skin, press for a few seconds with the palm of your
hand.
To avoid local irritation, wait a few days before reusing the same
application area.
In case of patch detachment, apply a new device to another site.
Apply the patch following these instructions:

• remove the patch from the sachet;
• grasp a tab and pull gently;
• apply the adhesive part released from the tab to the chosen area;
• grasp the remaining tab and pull gently;
• make it adhere by applying light pressure on the patch for about 10 seconds until perfect adhesion.

Use in elderly patients
Normally, it is not necessary to modify the dose; your doctor will prescribe the most suitable dose for you.

If you use more Keritrina than you should
If you accidentally apply too many patches, remove the patches, then immediately inform your doctor or go to the nearest hospital.
While waiting for the doctor, it is necessary to raise your legs to combat low blood pressure or
bandage your legs so that some pressure is exerted.
High doses of nitroglycerin can cause

• low blood pressure
• increased heart rate
• collapse
• fainting. A blood disorder (metahemoglobinemia) has been reported following overdose.

If you forget to use Keritrina
If you forget to change the Keritrina patch at the scheduled time, change it as soon as you remember and apply
the new patch as described above.
If you forget to use the patch one day, do not apply 2 or more patches at the same time to compensate
for forgetting the patch from the previous day.

If you stop using Keritrina
Do not abruptly interrupt the therapy.
If you switch from chronic treatment to another type of treatment, nitroglycerin must be discontinued
gradually (within 4-6 weeks), while starting the new treatment.
If you have any doubts about 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.

Very common side effects(may affect more than 1 in 10 people)

• nausea and vomiting.

Common side effects(may affect up to 1 in 10 people)

• headache. The headache often subsides after a few days, without the need to stop therapy. If you have a headache even with intermittent therapy, you can use mild analgesics. If the headache does not respond to this type of treatment, consult your doctor who will assess whether it is appropriate to reduce the dose of nitroglycerin or stop treatment.

Uncommon side effects(may affect up to 1 in 100 people)

• contact dermatitis (skin inflammation with symptoms such as redness, itching and skin scaling);
• rash on the skin where you applied the patch with itching, redness, burning sensation, skin irritation. Any mild skin redness usually disappears a few hours after you remove the patch. Change the patch application site regularly to prevent local irritation.

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

• increased heart rate;
• tachycardia;
• sudden drop in blood pressure, especially when standing up;
• hot flashes.

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

• dizziness.

Side effects with unknown frequency(frequency cannot be estimated from available data)

• palpitations;
• rash on large areas of skin.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Keritrina

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Keritrina contains
Keritrina 5 mg/24 hours transdermal patches

• The active ingredient is nitroglycerin. Each patch with a surface area of 7 cm² contains 22.4 mg of nitroglycerin, released over 24 hours.
• The other ingredients are: acrylic copolymer, sorbitan monooleate.
• Patch composition: siliconized polyester, low-density polyethylene.

Keritrina 10 mg/24 hours transdermal patches

• The active ingredient is nitroglycerin. Each patch with a surface area of 14 cm² contains 44.8 mg of nitroglycerin, released over 24 hours.
• The other ingredients are: acrylic copolymer, sorbitan monooleate.
• Patch composition: siliconized polyester, low-density polyethylene.

Keritrina 15 mg/24 hours transdermal patches

• The active ingredient is nitroglycerin. Each patch with a surface area of 21 cm² contains 67.2 mg of nitroglycerin, released over 24 hours.
• The other ingredients are: acrylic copolymer, sorbitan monooleate.
• Patch composition: siliconized polyester, low-density polyethylene.

Description of the appearance of Keritrina and contents of the pack
Pack of 15 transdermal patches.

Marketing authorization holder and manufacturer
Marketing authorization holder
Lavipharm S.A.
via Agias Marinas, GR-190 02 Peania, Attica, Greece
Manufacturer
Lavipharm S.A.
via Agias Marinas, GR-190 02 Peania, Attica, Greece