LISINOPRIL 5 mg Coated Tablet

Зміст інструкції

1. Lisinopril ratiopharm 5 mg tablets, 20 mg tablets
   1. What is Lisinopril ratiopharm and what is it used for
   2. What you need to know before taking Lisinopril ratiopharm
   3. How to take Lisinopril ratiopharm
   4. Possible side effects
2. Lisinopril ratiopharm may cause a reduction in the number of white blood cells, with
   1. How to store Lisinopril ratiopharm
   2. Package Contents and Other Information

Lisinopril ratiopharm 5 mg tablets, 20 mg tablets

Lisinopril (as dihydrate)

Generic Equivalent Medicine

Read this leaflet carefully before taking 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. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Lisinopril ratiopharm and what is it used for

Lisinopril ratiopharmbelongs to a group of medicines called ACE inhibitors(Angiotensin Converting Enzyme Inhibitors). Lisinopril ratiopharmworks by widening the blood
vessels, reducing blood pressure and making it easier for your heart to pump the
blood to all parts of the body. Your doctor has prescribed Lisinopril ratiopharmfor one
of the following reasons:

• Your blood pressureis too high(hypertension).
• You suffer from a heart condition called symptomatic heart failure, due to which the heart does not pump blood adequately to all districts of the body as it should.
• You have had a heart attack(myocardial infarction) which can weaken the heart.
• You suffer from kidney problemsrelated to diabetes and high blood pressure.

2. What you need to know before taking Lisinopril ratiopharm

Do not takeLisinopril ratiopharm:

• if you are allergic to Lisinoprilor to any of the other ingredients of this medicine (listed in section 6) or to other ACE inhibitors;
• if you have previously experienced hypersensitivity reactions after using an ACE inhibitor manifested with swelling of the hands, feet or ankles, or even of the face, lips, tongue and/or throat, resulting in difficulty swallowing or breathing (angioedema);
• if a relative of yours has suffered from angioedema (there may be a family predisposition) or you yourself have experienced angioedema in other circumstances or for other reasons;
• if you are more than three months pregnant. (It is best to avoid Lisinopril ratiopharmin the early stages of pregnancy - see section Pregnancy);
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren; if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

If you have any doubts about whether or not to start therapy with Lisinopril ratiopharm, consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lisinopril ratiopharm

• if you are dehydrated as a result of treatment with diuretics, dialysis or a low-sodium diet or prolonged episodes of vomiting or diarrhea. In these cases, it is more likely that a severe drop in blood pressure (hypotension) will occur when you start taking the tablets, which can cause possible fainting or dizziness;
• if you have been diagnosed with a thickening of the heart muscle or a narrowing of the heart valves (mitral or aortic valve) or of the aorta;
• if you suffer from low blood pressure;
• if you are taking potassium supplements or saline substitutes containing potassium;
• if you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes;
• aliskiren. 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 the section "Do not take Lisinopril ratiopharm”
• if you have kidney problems or suffer from narrowing of the renal blood vessels;
• if you have had a kidney transplant;
• if you need hemodialysis;
• if you suffer from liver problems;
• if you suffer from diabetes;
• if you suffer from a collagen vascular disease, e.g. scleroderma, SLE (lupus);
• if you are going to undergo general or spinal anesthesia, inform your doctor, dentist or hospital medical staff;
• if you need treatment for blood separation (apheresis) or desensitizing treatment for allergy (e.g. to bee or wasp stings); your doctor may decide to stop treatment with Lisinopril ratiopharmto prevent a possible allergic reaction;
• if you are using medicines containing lithium, used for the treatment of manic-depressive disorders;
• if you are taking any of the following drugs, the risk of angioedema may be increased:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent organ rejection and to treat cancer (such as temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.
• you should inform your doctor if you think you are pregnant (or might become pregnant). Lisinopril ratiopharmis not recommended during the first months of pregnancy and should not be taken after the third month, as it may cause serious harm to the baby if used during this phase (see section Pregnancy).

While using Lisinopril ratiopharm
If you experience the following symptoms, you should inform your doctor immediately:

• Feeling dizzy after the first dose. Some people react after the first dose of the drug or after an increase in the usual dose, experiencing dizziness, weakness, feeling faint and unwell.
• Sudden swelling of lips, face, neck and, possibly, hands and feet, with difficulty swallowing, hives and difficulty breathing, or still wheezing and hoarseness. The combination of these symptoms is called angioedema, and can occur at any time during treatment. ACE inhibitors cause a higher number of angioedema in populations of color compared to those not of color.
• High body temperature, sore throat or mouth ulcers (all symptoms of possible infection caused by a decrease in white blood cells).
• Yellowing of the skin and the white part (sclera) of the eyes (jaundice), which indicates liver problems.

At the beginning of treatment and/or during the dosage adjustment period, it may be
necessary to increase the frequency of medical check-ups. You must attend all visits,
even if you feel well. Your doctor will tell you the exact frequency of check-ups.

Children and adolescents
Donot administer Lisinopril ratiopharmto children under 6 years of age or to children
with severe kidney impairment. Limited information is available regarding
efficacy and safety in children with high blood pressure under 6 years of age, but no
further indications are available.

Other medicinesandLisinopril ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. These include herbal remedies, health products or supplements purchased on your own initiative. This recommendation
also applies to medicines or herbal products taken/used in the past. Some medicines
can interfere with the action of other drugs.

Tell your doctor if you are taking any of the following medicines:

• Diuretics(including those that preserve potassium).
• Antihypertensives(other medicines for the treatment of high blood pressure).
• Nitroglycerinand other nitrates (for coronary artery disease, angina pectoris).
• Acetylsalicylic acid(high doses of aspirin, more than 3 grams per day) or any other non-steroidal anti-inflammatory drug(NSAID), such as indometacin(medicine used to treat arthritis or muscle pain).
• Lithium(for manic-depressive disorders).
• Antipsychotics,antidepressantstricyclic(drugs for mental disorders) or barbiturates.
• Potassium supplements(including salt substitutes), potassium-sparing diureticsand other medicines that may increase the amount of potassium in the blood

(such as trimethoprim and cotrimoxazolefor treating bacterial infections;

cyclosporine, an immunosuppressant medicine used to prevent organ rejection
transplants; and heparin, a medicine used to thin the blood and prevent
the formation of clots).

• Potassium in tablets or liquidsor saline supplements containing potassium, other drugsthat can increase potassium levelsin the body (including heparin and cotrimoxazole also known as trimethoprim/sulfamethoxazole).
• Oral antidiabetic drugs(tablets to lower blood sugar levels) or insulin(medicine for the treatment of diabetes).
• Sympathomimetic drugs(medicines that stimulate the central nervous system), such as ephedrine, pseudoephedrineand salbutamol,which are also found in some nasal decongestants, cough/cold remedies and asthma medications.
• Immunosuppressants(medicines that suppress the response of the immune system), allopurinol(for gout) or procainamide(for irregular heartbeat).
• Gold.
• Drugs commonly used to prevent organ rejection(sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

Your doctor may need to adjust the dose and/or take other precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren
(see also the section "Do not take Lisinopril ratiopharm” and "Warnings and
precautions").

Lisinopril ratiopharmwith food, drinks and alcohol
Do not use potassium supplements or saline substitutes containing potassium while you are being treated with

Lisinopril ratiopharm. The blood potassium level may, in fact, increase excessively.
Do not use excessive amounts of salt (sodium chloride), as salt can raise
blood pressure and reduce the effectiveness of Lisinopril ratiopharm.
Drinking alcohol may enhance the effect of Lisinopril ratiopharm.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your
doctor or pharmacist for advice before taking
this medicine.
Pregnancy
You should tell your doctor if you think you are (or might become) pregnant. Your
doctor will usually advise you to stop taking Lisinopril ratiopharmbefore
pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine in
instead of Lisinopril ratiopharm. Lisinopril ratiopharmis not recommended in the first months of
pregnancy and should not be taken after the third month of pregnancy as it may cause
serious harm to the baby if used after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Lisinopril ratiopharm
is not recommended for mothers who are breastfeeding and your doctor may choose a
different treatment if you wish to breastfeed, especially if it is a newborn or was
prematurely born.

Driving and operating machinery
It is unlikely that Lisinopril ratiopharmtablets will affect your ability to drive or
operate machinery. However, you should not engage in activities that require particular
attention until you know how you react to the medicine.
If you have any doubts about whether or not to start treatment with Lisinopril ratiopharm, you should
contact your doctor.
Lisinopril contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is
essentially "sodium-free".

3. How to take Lisinopril ratiopharm

Always take Lisinopril ratiopharmexactly as your doctor or pharmacist has instructed. If you have any doubts, consult your doctor or pharmacist.

How much medicine to take
Your doctor will tell you how many tablets you need to take each day. The dosage is
individualized, and it is important that you follow the medical prescriptions exactly. The initial dose and the long-term dose depend on your health condition and any
concomitant use of other medicines. Consult your doctor or pharmacist if you have any doubts.
The recommended doseis:

Lisinopril ratiopharm 5 mg

For high blood pressure
The recommended initial dose is 2 tablets of Lisinopril ratiopharm 5 mg(10 mg of
lisinopril) once a day. The usual dose in the long term is instead 4 tablets of

Lisinopril ratiopharm 5 mg(20 mg of lisinopril) once a day.
For children (aged 6-16 years) with high blood pressure
The recommended initial dose is usually ½ tablet of Lisinopril ratiopharm 5 mg
(2.5 mg of Lisinopril) in patients weighing 20 to 50 kg and 1 tablet of Lisinopril ratiopharm 5 mg
(5 mg of Lisinopril) in patients > 50 kg once a day. Your doctor may adjust the
dose individually up to a maximum of 20 mg/day in patients weighing 20 to 50 kg and 40
mg/day in patients weighing more than 50 kg.
Your doctor may prescribe a lower initial dose or may advise an increase
in the dosage interval for children with reduced kidney function.

For symptomatic heart failure
The recommended initial dose is ½ tablet of Lisinopril ratiopharm 5 mg(2.5 mg of
lisinopril) once a day. The usual dose in the long term varies instead from 1 to 7
tablets of Lisinopril ratiopharm 5 mg(from 5 to 35 mg of lisinopril) once a day.

After a heart attack
The recommended initial dose is 1 tablet of Lisinopril ratiopharm 5 mg(5 mg of
lisinopril) on the 1st and 2nd day, followed by 2 tablets of Lisinopril ratiopharm 5 mg(10
mg of lisinopril) once a day.

For diabetes-related problems
The usual dose is 2 or 4 tablets of Lisinopril ratiopharm 5 mg(10 mg or 20 mg of
lisinopril) once a day.
Kidney problems
The doctor may prescribe a reduced dose.

Lisinopril ratiopharm 20 mg

For high blood pressure
The recommended initial dose is ½ tablet of Lisinopril ratiopharm 20 mg(10 mg of
lisinopril) once a day. The usual dose in the long term is instead 1 tablet of

Lisinopril ratiopharm 20 mg(20 mg of lisinopril) once a day.
For children (aged 6-16 years) with high blood pressure
The recommended initial dose is usually Lisinopril ratiopharm 2.5 mgin patients weighing 20
to 50 kg (formulations with a more appropriate content
of active ingredient are available for this dosage) and Lisinopril ratiopharm5 mg in patients > 50 kg once a day. Your
doctor may adjust the dose individually up to a maximum of 20 mg/day in patients
weighing 20 to 50 kg and 40 mg/day in patients weighing more than 50 kg.
Your doctor may prescribe a lower initial dose or may advise an increase
in the dosage interval for children with reduced kidney function.

For symptomatic heart failure
The recommended initial dose is 2.5 mg once a day. The usual dose in the long
term varies instead from 5 to 35 mg once a day. Formulations with a more appropriate content of active ingredient are available
for this dosage.

After a heart attack
The recommended initial dose is 5 mg on the 1st and 2nd day, followed by ½ tablet of

Lisinopril ratiopharm 20 mg(10 mg of lisinopril) once a day. Formulations with a more appropriate content of active ingredient are available
for the initial dose.

For diabetes-related problems
The usual dose is ½ or 1 tablet of Lisinopril ratiopharm 20 mg(10 mg or 20 mg of
lisinopril) once a day.
Kidney problems
The doctor may prescribe a reduced dose.

How to take Lisinopril ratiopharm
The tablet should be swallowed with a glass of water. Try to take the
tablets at the same time each day. It does not matter if you take Lisinopril

ratiopharmbefore or after meals.
Remember: the first doseof Lisinopril ratiopharmmay cause a greater drop in
blood pressurethan occurs with continued therapy. You may therefore experience dizzinessor feeling of
lightheadedness, which may resolve by lying down in a supine position. If you are concerned, inform your doctoras soon as possible.
If you feel that the effect of Lisinopril ratiopharmis too strong or too weak,
inform your doctor or pharmacist as soon as possible.
If you take more Lisinopril ratiopharmthan you should
Contact your doctorimmediatelyor the nearest hospitalif you have taken more Lisinopril

ratiopharmthan you should (overdose). An overdose can cause a severe
lowering of blood pressure, which in turn can lead to dizziness and
vertigo. Possible symptoms also include shortness of breath, rapid or slow pulse,
palpitations, anxiety, or cough.
If you forget to take Lisinopril ratiopharm

Do nottake a double doseto make up for a missed tablet/dose.
Simply follow the usual schedule prescribed.
If you stop taking Lisinopril ratiopharm
Do not stop taking the tablets, even if you feel well, without explicit
medical advice.
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.
To assess side effects, the following frequency scale is used:

Important side effects or symptoms that may occur and measures to
manage them
You must stop taking Lisinopril ratiopharmand contact your doctor immediately if symptoms of angioedema appear, such as:

• swelling of the face, tongue or throat
• difficulty swallowing
• hives and difficulty breathing.

Lisinopril ratiopharm may cause a reduction in the number of white blood cells, with

consequent decrease in resistance to infections. If an infection occurs with
symptoms such as fever and serious deterioration of general conditions, or fever with
local symptoms of infection such as sore throat/pharynx/mouth or urinary problems, you should consult
your doctor immediately. A blood test should be performed to check for any
reduction in white blood cells (agranulocytosis). It is important to inform your doctor about
the medication you are taking.

Other possible undesirable effects
Patients affected by coronary artery disease or narrowing of the aorta (aortic stenosis), of the renal artery (renal artery stenosis) or heart valves (mitral valve stenosis), or
those who present a thickening of the heart muscle (hypertrophic cardiomyopathy)
may be subject to an excessive drop in blood pressure.

A complex of symptoms has been observed that includes one or more of the following
manifestations: fever, inflammation of blood vessels (vasculitis), muscle pain,
inflammation of one or more joints (arthralgia/arthritis), positive antinuclear antibodies
(ANA), elevated erythrocyte sedimentation rate (ESR), eosinophilia and leukocytosis, rash,
sensitivity to light (photosensitivity) or other dermatological manifestations.

Further undesirable effects in children and adolescents
Safety data from clinical studies indicate that lisinopril is generally well tolerated
in pediatric hypertensive patients and that the safety profile in children aged 6-
16 years is comparable to that seen in adults.

Reporting of undesirable effects

If you experience any side effects, including those not listed in this leaflet,
please inform your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse
. By reporting side effects you can contribute to providing more information about
the safety of this medicine.

5. How to store Lisinopril ratiopharm

Keep this medicine out of the sight and reach of children.
Do not use this medicineafter the expiry datewhich is reported on the blister and the carton
after Exp.. The expiry date refers to the last day of that month.

Lisinopril ratiopharm 5 mg and 20 mg
This medicine does not require special storage conditions.
Do not dispose of any medicine in the waste wateror in household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Lisinopril ratiopharmcontains
The active ingredient is: lisinopril dihydrate.

Lisinopril ratiopharm 5 mg
Each tablet contains 5 mg of lisinopril (as dihydrate).

Lisinopril ratiopharm 20 mg
Each tablet contains 20 mg of lisinopril (as dihydrate).
The excipients are:

Lisinopril ratiopharm 5 mg
Mannitol, dibasic calcium phosphate dihydrate, pregelatinized corn starch, croscarmellose
sodium, magnesium stearate.

Lisinopril ratiopharm 20 mg
Mannitol, dibasic calcium phosphate dihydrate, pregelatinized corn starch, croscarmellose
sodium, magnesium stearate, iron oxide (III), iron oxide (II,III), iron(III) hydroxide (E
172).
Description of the appearance of Lisinopril ratiopharmand package contents

Lisinopril ratiopharm 5 mg
Round, uncoated, biconvex, divisible tablets with a score line, of
color
white and without inscriptions.

Lisinopril ratiopharm 20 mg
Round, uncoated, biconvex, divisible tablets with a score line, of
color
pink and without inscriptions.
The tablets of Lisinopril ratiopharmare available in 2 strengths: 5 mg and 20 mg.

Lisinopril ratiopharm 5 mg
Is available in PVC-aluminum blisters containing 1, 14, 20, 28, 30, 30x1, 50, 56, 60, 98,
100, 100x1, 400 (10 x 40), 500 tablets and in bottles of 100, 250 tablets.

Lisinopril ratiopharm 20 mg
Is available in PVC-aluminum blisters containing 1, 14, 28, 30, 30x1, 50, 56, 60, 98, 100,
100x1, 400 (10 x 40), 500 tablets and in bottles of 100, 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
ratiopharm GmbH, Graf-Arco Strasse 3, Ulm (Germany)

Manufacturer
Merckle GmbH - Ludwig-Merckle Strasse 3 - D-89143 Blaubeuren (Germany)