Lisinopril Ratiopharm

Package leaflet: Information for the user

Lisinopril ratiopharm 5 mg tablets, 20 mg tablets

Lisinopril (as dihydrate)
Generic Medicine
Please read all of this leaflet carefully before taking this medicine because 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, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Lisinopril ratiopharm is and what it is used for
2. What you need to know before taking 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 Lisinopril ratiopharm is and what it is used for

Lisinopril ratiopharm belongs to a group of medicines called ACE inhibitors (Angiotensin-Converting Enzyme inhibitors). Lisinopril ratiopharm works by dilating blood vessels, thereby lowering blood pressure and making it easier for your heart to pump blood throughout the body. Your doctor has prescribed Lisinopril ratiopharm for one of the following reasons:

• Your blood pressure is too high (hypertension).
• You have a heart condition called symptomatic heart failure, in which the heart does not pump blood adequately to the body's tissues.
• You have had a heart attack (myocardial infarction), which may weaken the heart.
• You have kidney problems related to diabetes and high blood pressure.

2. What you should know before taking Lisinopril ratiopharm

Do not take Lisinopril ratiopharm if:

• you are allergic to Lisinopril or to any of the other ingredients of this medicine (listed in section 6) or to other ACE inhibitors;
• you have previously experienced hypersensitivity reactions after taking an ACE inhibitor, such as swelling of the hands, feet or ankles, or of the face, lips, tongue and/or throat, causing difficulty in swallowing or breathing (angioedema);
• a family member has suffered from angioedema (there may be a familial predisposition), or if you yourself have previously experienced angioedema under other circumstances or due to other causes;
• you are beyond the third month of pregnancy. (It is advisable to avoid Lisinopril ratiopharm during early pregnancy – see section on Pregnancy);
• you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren; if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling beneath the skin, for example in the throat).

If you have any doubts about whether or not to start treatment with Lisinopril ratiopharm,
please consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lisinopril ratiopharm

• if you are dehydrated due to diuretic treatment, dialysis, a low-sodium diet, or prolonged episodes of vomiting or diarrhoea. In such cases, a significant drop in blood pressure (hypotension) is more likely when starting the tablets, which may cause fainting or dizziness;
• if you have been diagnosed with thickening of the heart muscle or 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 potassium-containing salt substitutes;
• 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 (e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "Do not take Lisinopril ratiopharm".
• if you have kidney problems or narrowing of the renal blood vessels;
• if you have had a kidney transplant;
• if you require haemodialysis;
• if you have liver problems;
• if you have diabetes;
• if you have a collagen vascular disease, e.g. scleroderma, SLE (lupus);
• if you are undergoing surgery with general or spinal anaesthesia, inform your doctor, dentist or hospital medical staff;
• if you require blood separation treatment (apheresis) or desensitisation treatment for allergy (e.g. to bee or wasp stings); your doctor may decide to discontinue treatment with Lisinopril ratiopharm to prevent a possible allergic reaction;
• if you are taking medicines containing lithium, used to treat manic-depressive disorders;
• if you are taking any of the following medicines, the risk of angioedema may be increased:
• racecadotril, a medicine used to treat diarrhoea;
• medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.
• you must inform your doctor if you think you are pregnant (or suspect you might become pregnant). Lisinopril ratiopharm is not recommended during the first months of pregnancy and must not be taken beyond the third month, as it may cause serious harm to the unborn child if used during this period (see section on Pregnancy).

While using Lisinopril ratiopharm
If any of the following symptoms occur, you must inform your doctor immediately:

• Dizziness after the first dose. Some people may experience dizziness, weakness, fainting or general malaise after the first dose or after an increase in the usual dose.
• Sudden swelling of lips, face, neck, and possibly hands and feet, with difficulty in swallowing, hives and breathing difficulties, or shortness of breath and hoarseness. This set of symptoms is known as angioedema and may occur at any time during treatment. ACE inhibitors cause angioedema more frequently in people of colour than in those who are not.
• High body temperature, sore throat or mouth ulcers (all signs of a possible infection due to decreased white blood cells).
• Yellowing of the skin and whites of the eyes (sclera) (jaundice), indicating possible liver problems.

At the beginning of treatment and/or during the dose adjustment period, more frequent medical
check-ups may be necessary. You must attend all appointments, even if you feel well. Your
doctor will inform you of the exact frequency of check-ups.
Children and adolescents
Do not administer Lisinopril ratiopharm to children under 6 years of age or to children
with severe renal impairment. Limited data are available on efficacy and safety in children
under 6 years of age with high blood pressure, and no other indications are available.
Other medicines and Lisinopril ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines. This includes herbal remedies, wellness products or supplements purchased
on your own initiative. This recommendation also applies to medicines or herbal products taken
or used in the past. Some medicines may interfere with the action of other drugs.
Inform your doctor if you are taking any of the following medicines:

• Diuretics (including potassium-sparing diuretics).
• Antihypertensives (other medicines for high blood pressure).
• Nitroglycerine and other nitrates (for coronary artery disease, angina pectoris).
• Acetylsalicylic acid (high-dose aspirin, more than 3 grams per day) or any other non-steroidal anti-inflammatory drug (NSAID), such as indomethacin (a medicine used to treat arthritis or muscle pain).
• Lithium (for manic-depressive disorders).
• Antipsychotics, tricyclic antidepressants (medicines for mental disorders) or barbiturates.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels

(such as trimethoprim and cotrimoxazole used to treat bacterial infections;
cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clot formation).

• Potassium tablets or liquids or potassium-containing salt substitutes, other drugs that may increase potassium levels in the body (including heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole).
• Oral antidiabetic drugs (tablets to lower blood sugar levels) or insulin (a medicine for treating diabetes).
• Sympathomimetic drugs (medicines that stimulate the central nervous system), such as ephedrine, pseudoephedrine and salbutamol, also found in some nasal decongestants, cough/cold remedies and asthma medicines.
• Immunosuppressants (medicines that suppress the immune response), allopurinol (for gout) or procainamide (for abnormal heart rhythm).
• Gold.
• Medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See section "Warnings and precautions".

Your doctor may consider it necessary to adjust the dose and/or take other precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren
(see also the sections "Do not take Lisinopril ratiopharm" and "Warnings and precautions").
Lisinopril ratiopharm with food, drinks and alcohol
Do not use potassium-containing salt substitutes or supplements while taking
Lisinopril ratiopharm. Blood potassium levels may rise excessively.
Do not use excessive amounts of salt (sodium chloride), as salt may raise blood pressure and reduce the effectiveness of Lisinopril ratiopharm.
Alcohol consumption may enhance the effect of Lisinopril ratiopharm.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise stopping Lisinopril ratiopharm before pregnancy or as soon as pregnancy is detected, and will recommend an alternative medicine. Lisinopril ratiopharm is not recommended during the first months of pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if used beyond this point.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Lisinopril ratiopharm
is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the infant is a newborn or was born prematurely.
Driving and using machines
It is unlikely that Lisinopril ratiopharm tablets will affect your ability to drive or operate machinery. However, you should not engage in activities requiring special 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, i.e. essentially "sodium-free".

3. How to take Lisinopril ratiopharm

Always take Lisinopril ratiopharm exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
How much medicine to take
Your doctor will tell you how many tablets to take each day. The dosage is
individual, and it is important that you follow your doctor's instructions precisely. The initial and long-term doses depend on your health condition and whether you are taking other medicines at the same time. Contact your doctor or pharmacist if you have any questions.
The recommended dose is:
Lisinopril ratiopharm 5 mg
For high blood pressure
The recommended starting dose is 2 tablets of Lisinopril ratiopharm 5 mg (10 mg of
lisinopril) once daily. The usual long-term dose is 4 tablets of Lisinopril ratiopharm 5 mg
(20 mg of lisinopril) once daily.
For children (aged 6–16 years) with high blood pressure
The usual recommended starting dose is ½ tablet of Lisinopril ratiopharm 5 mg
(2.5 mg of lisinopril) for patients weighing 20–50 kg and 1 tablet of Lisinopril ratiopharm 5 mg
(5 mg of lisinopril) for patients > 50 kg, once daily. Your doctor may adjust the
dose individually up to a maximum of 20 mg/day in patients weighing 20–50 kg and 40
mg/day in patients over 50 kg.
Your doctor may prescribe a lower starting dose or recommend a longer dosing interval for children with reduced kidney function.
For symptomatic heart failure
The recommended starting dose is ½ tablet of Lisinopril ratiopharm 5 mg (2.5 mg of
lisinopril) once daily. The usual long-term dose ranges from 1 to 7 tablets of Lisinopril ratiopharm 5 mg
(from 5 to 35 mg of lisinopril) once daily.
After a heart attack
The recommended starting dose is 1 tablet of Lisinopril ratiopharm 5 mg (5 mg of
lisinopril) on day 1 and day 2, followed by 2 tablets of Lisinopril ratiopharm 5 mg (10
mg of lisinopril) once daily.
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 daily.
Kidney problems
Your doctor may prescribe a reduced dose.
Lisinopril ratiopharm 20 mg
For high blood pressure
The recommended starting dose is ½ tablet of Lisinopril ratiopharm 20 mg (10 mg of
lisinopril) once daily. The usual long-term dose is 1 tablet of Lisinopril ratiopharm 20 mg
(20 mg of lisinopril) once daily.
For children (aged 6–16 years) with high blood pressure
The usual recommended starting dose is Lisinopril ratiopharm 2.5 mg for patients weighing 20–50 kg (formulations with a more appropriate active ingredient content are available for this dose) and Lisinopril ratiopharm 5 mg for patients > 50 kg, once daily. Your doctor may adjust the dose individually up to a maximum of 20 mg/day in patients weighing 20–50 kg and 40 mg/day in patients over 50 kg.
Your doctor may prescribe a lower starting dose or recommend a longer dosing interval for children with reduced kidney function.
For symptomatic heart failure
The recommended starting dose is 2.5 mg once daily. The usual long-term dose ranges from 5 to 35 mg once daily. Formulations with a more appropriate active ingredient content are available for this dose.
After a heart attack
The recommended starting dose is 5 mg on day 1 and day 2, followed by ½ tablet of Lisinopril ratiopharm 20 mg (10 mg of lisinopril) once daily. Formulations with a more appropriate active ingredient content 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 daily.
Kidney problems
Your 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 whether you take Lisinopril ratiopharm before or after meals.
Remember: the first dose of Lisinopril ratiopharm may cause a greater drop in blood pressure
than occurs during continued treatment. You may therefore experience dizziness or lightheadedness, which can be relieved by lying down flat. If you are concerned, inform your doctor as soon as possible.
If you feel that the effect of Lisinopril ratiopharm is too strong or too weak, inform your doctor or pharmacist as soon as possible.
If you take more Lisinopril ratiopharm than you should
Contact your doctor or the nearest hospital immediately if you have taken more Lisinopril ratiopharm than prescribed (overdose). An overdose can cause a severe drop in blood pressure, which may lead to lightheadedness and dizziness. Other possible symptoms include shortness of breath, rapid or slow pulse, palpitations, anxiety, or cough.
If you forget to take Lisinopril ratiopharm
Do not take a double dose to make up for a missed tablet/dose.
Simply continue with your prescribed dosing schedule.
If you stop taking Lisinopril ratiopharm
Do not stop taking the tablets, even if you feel well, unless explicitly advised by your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following frequency scale is used to assess side effects:

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

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

Lisinopril ratiopharm may cause a reduction in the number of white blood cells, resulting in decreased resistance to infections. If an infection occurs with symptoms such as fever and severe worsening of general condition, or fever accompanied by local signs of infection such as sore throat/pharynx/mouth or urinary problems, you must consult your doctor immediately. A blood test should be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important to inform your doctor about the medication you are taking.
Other possible side effects

Patients with coronary artery disease or narrowing of the aorta (aortic stenosis), renal artery (renal artery stenosis), or heart valves (mitral valve stenosis), or those with thickening of the heart muscle (hypertrophic cardiomyopathy), may be subject to excessive lowering of blood pressure.

A complex of symptoms has been observed, including 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, skin rash, light sensitivity (photosensitivity), or other dermatological manifestations.

Additional adverse 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 observed in adults.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at the following website:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse effects, you can help provide more information on 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 medicine after the expiry date stated on the blister and carton
afterExp.. 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 medicines via wastewater or 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 ratiopharm contains
The active substance 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 maize starch, croscarmellose sodium, magnesium stearate.
Lisinopril ratiopharm 20 mg
Mannitol, dibasic calcium phosphate dihydrate, pregelatinized maize starch, croscarmellose sodium, magnesium stearate, iron(III) oxide, iron(II,III) oxide, iron(III) hydroxide (E 172).

Description of the appearance of Lisinopril ratiopharm and contents of the pack
Lisinopril ratiopharm 5 mg
Round-shaped, uncoated, biconvex tablets, divisible with a break line, white in colour and without any markings.
Lisinopril ratiopharm 20 mg
Round-shaped, uncoated, biconvex tablets, divisible with a break line, pink in colour and without any markings.
Lisinopril ratiopharm tablets are available in two strengths: 5 mg and 20 mg.
Lisinopril ratiopharm 5 mg
Available in PVC-aluminium blisters containing 1, 14, 20, 28, 30, 30x1, 50, 56, 60, 98, 100, 100x1, 400 (10 x 40), 500 tablets and in bottles containing 100, 250 tablets.
Lisinopril ratiopharm 20 mg
Available in PVC-aluminium blisters containing 1, 14, 28, 30, 30x1, 50, 56, 60, 98, 100, 100x1, 400 (10 x 40), 500 tablets and in bottles containing 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)