Skopril Plus

Leaflet accompanying the packaging: information for the user

Skopryl plus, 20 mg + 12.5 mg, tablets

Lisinopril + Hydrochlorothiazide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What Skopryl plus is and what it is used for
• 2. Important information before taking Skopryl plus
• 3. How to take Skopryl plus
• 4. Possible side effects
• 5. How to store Skopryl plus
• 6. Contents of the packaging and other information

1. What Skopryl plus is and what it is used for

Skopryl plus in tablet form contains two active ingredients: lisinopril and hydrochlorothiazide. It is used to treat high blood pressure. If high blood pressure is not treated, the risk of heart disease and stroke increases. Lisinopril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). Its action is to dilate blood vessels, which lowers elevated blood pressure. Hydrochlorothiazide belongs to a group of medicines called diuretics. It increases the amount of urine excreted, which causes the body to get rid of excess water. The action of Skopryl plus is to lower blood pressure, which reduces the risk of heart disease and stroke.

2. Important information before taking Skopryl plus

When not to take Skopryl plus:

• If the patient is allergic to lisinopril and/or hydrochlorothiazide, and/or to any of the other ingredients of this medicine (listed in section 6).
• If the patient has previously been treated with an ACE inhibitor and has experienced an allergic reaction with symptoms such as swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing (angioedema).
• If the patient is allergic to sulphonamide-derived medicines, such as certain antibiotics and antidiabetic medicines (if in doubt, consult a doctor).
• If the patient has been diagnosed with hereditary or idiopathic angioedema (severe skin swelling, especially around the eyes, lips, nose, tongue, larynx, or hands). This means that the patient was either born with this condition or the cause of this condition is unknown.
• After the third month of pregnancy (it is also recommended to avoid taking Skopryl plus in early pregnancy - see section "Pregnancy, breastfeeding, and fertility").
• If the patient has severe liver dysfunction.
• If the patient has severe kidney dysfunction.
• If the patient is unable to urinate (anuria).
• If the patient has high levels of potassium in the blood.
• If the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.
• If the patient has taken or is currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat) increases.

If any of the above points apply to the patient or if the patient has any doubts, they should discuss this with their doctor.

Warnings and precautions

Before starting to take Skopryl plus, the patient should discuss this with their doctor or pharmacist. The patient should tell their doctor if:

• The patient has or has had any health problems, allergies, or asthma.
• The patient has liver, kidney, or heart disease.
• The patient has a disease of the blood vessels in the brain (a group of diseases that affect blood flow and blood vessels in the brain).
• The patient has a certain heart disease called aortic or mitral stenosis.
• The patient is undergoing dialysis.
• The patient has had a kidney transplant.
• The patient has recently had severe vomiting or diarrhea.
• The patient has been informed that they have abnormal levels of certain electrolytes and substances in their blood: potassium, calcium, urea, creatinine, uric acid, cholesterol, or triglycerides.
• The patient has gout (painful swelling of the joints caused by the accumulation of uric acid).
• The patient has systemic lupus erythematosus (a chronic autoimmune disease that can occur in any part of the body).
• The patient develops jaundice (yellowing of the skin and/or eyes).
• The patient has diabetes (the doctor may monitor the patient's condition during the first month of treatment).
• The patient is pregnant, plans to become pregnant, or suspects they are pregnant. Skopryl plus is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may harm the baby (see section "Pregnancy").
• The patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan - for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes,
• aliskiren.
• There is a risk of angioedema (rapid swelling of tissues under the skin, such as in the throat).
• If the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive accumulation of fluid between the choroid and sclera) or increased pressure inside the eye - these symptoms can occur within a few hours to weeks after taking Skopryl plus. Without treatment, the symptoms can lead to complete loss of vision. If the patient has previously been allergic to penicillin or sulphonamides, they may be at increased risk of developing these symptoms.
• If the patient has a history of skin cancer or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During treatment with Skopryl plus, the patient should protect their skin from sunlight and UV radiation.
• If the patient has a history of breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient experiences severe shortness of breath or difficulty breathing after taking Skopryl plus, they should seek medical help immediately.

If the patient is taking any of the following medicines, the risk of angioedema may increase:

• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent the rejection of transplanted organs and to treat cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the section "When not to take Skopryl plus". If the patient is to undergo desensitization treatment, i.e., treatment that reduces the effects of an allergy to bee or wasp venom, they should inform the doctor performing the procedure that they are taking Skopryl plus. If the patient is to undergo LDL apheresis, a procedure that removes cholesterol from the blood using a special device, they should inform the doctor performing the procedure that they are taking Skopryl plus.

Planned surgical procedure

Before surgery and anesthesia (even at the dentist), the patient should inform their doctor or dentist that they are taking Skopryl plus, due to the risk of a sudden drop in blood pressure.

Children and adolescents

Skopryl plus is not intended for use in children.

Skopryl plus and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Skopryl plus may affect the action of other medicines, and other medicines may affect the action of Skopryl plus. The doctor may recommend a change in dose and/or take other precautions:

• If the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to take Skopryl plus" and "Warnings and precautions").

It is especially important to inform the doctor about taking any of the following medicines:

• Insulin or tablets that lower blood sugar levels (medicines used to treat diabetes, such as vildagliptin).
• Medicines used to treat mental disorders, such as lithium salts or antipsychotic medicines.
• Allopurinol, a medicine used to treat gout.
• Medicines used to treat cancer.
• Sotalol or procainamide, medicines used to treat heart rhythm disorders.
• Medicines used to treat indigestion (e.g., antacids).
• Medicines such as ephedrine, noradrenaline, or adrenaline (epinephrine) used to treat low blood pressure, shock, heart failure, asthma, or allergies.
• Sedatives or anxiolytics (tranquilizers).
• Cholestyramine, colestipol, or lovastatin, which are used to treat hyperlipidemia (high cholesterol levels in the blood).
• Diuretics (diuretic medicines) - if the patient is already taking a diuretic, the doctor may recommend reducing the dose or even stopping it before starting to take Skopryl plus.
• Other medicines used to treat high blood pressure, as they may enhance the blood pressure-lowering effect of Skopryl plus.
• Steroids used to treat various diseases, including rheumatism, arthritis, allergic diseases, certain skin diseases, asthma, or blood diseases.
• Non-steroidal anti-inflammatory medicines (NSAIDs) (a group of pain-relieving medicines, e.g., indomethacin).
• Opioid pain-relieving medicines (e.g., codeine, dextropropoxyphene, diamorphine, morphine, pentazocine, pethidine).
• Immunosuppressive medicines, such as cyclosporine, used after organ transplantation and to treat diseases such as rheumatoid arthritis.
• ACTH used in a test to assess adrenal function,
• Amphotericin B injections, a medicine used to treat fungal infections.
• Laxative stimulants, medicines used to treat constipation,
• Cardiac glycosides, such as digoxin, used to treat heart diseases.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (diuretic tablets, in particular those from the group of potassium-sparing diuretics) and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, a combination of trimethoprim and sulfamethoxazole, used in bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ rejection and hepatitis; heparin, a medicine used to thin the blood to prevent blood clots).
• Calcium supplements.
• Antidepressant and/or antipsychotic medicines.
• Gold salts given by injection (used to treat rheumatoid arthritis).
• Tubocurarine (a muscle relaxant used during anesthesia).
• Medicines that are commonly used to prevent the rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section "Warnings and precautions".
• Racecadotril, a medicine used to treat diarrhea.

The patient should remember that taking this medicine may affect the results of blood and urine tests. The patient should inform their doctor before each test that they are taking Skopryl plus.

Skopryl plus with food, drink, and alcohol

This medicine can be taken with or without food. The action of blood pressure-lowering medicines may be enhanced if alcohol is consumed at the same time, which can cause dizziness or a feeling of "emptiness" in the head. If the patient has any doubts about the amount of alcohol they can drink while taking Skopryl plus, they should consult their doctor.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist. Pregnancy The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Skopryl plus before planned pregnancy or as soon as pregnancy is confirmed and recommend taking a different medicine instead of Skopryl plus. Skopryl plus is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may harm the baby. Breastfeeding The patient should inform their doctor about breastfeeding or intending to breastfeed. Skopryl plus is not recommended during breastfeeding. The doctor will recommend taking a different medicine if the patient wants to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

Skopryl plus may mildly affect the ability to drive or operate machines, especially at the start of treatment or when changing the dose and when taken with alcohol. When driving or operating machines, the patient should take into account that dizziness and fatigue may occasionally occur.

3. How to take Skopryl plus

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. The recommended dose is one tablet once a day. If necessary, the doctor may increase the dose to two tablets once a day. Skopryl plus can be taken at any time of day, before, during, or after meals. The patient should choose a convenient time to take the medicine and take the tablet at the same time every day. This will help the patient remember to take the medicine regularly. The patient should be particularly careful after taking the first dose or after increasing the dose. If dizziness or a feeling of "emptiness" in the head occurs, the patient should immediately inform their doctor. If the patient has previously taken a diuretic, the doctor may recommend reducing the dose or even stopping it before starting to take Skopryl plus. Since the action of Skopryl plus lasts for 24 hours, the medicine is taken once a day. The dividing line on the tablet only makes it easier to break the tablet for easier swallowing.

Taking a higher dose of Skopryl plus than recommended

If the patient takes a higher dose of Skopryl plus than recommended, they should immediately consult their doctor or go to the emergency department of the nearest hospital. The most likely symptoms of overdose are a feeling of "emptiness" in the head or dizziness caused by low blood pressure.

Missing a dose of Skopryl plus

The patient should not take a double dose to make up for a missed dose. The patient should take the next tablet at the usual time the next day.

Stopping treatment with Skopryl plus

The medicine should be taken for as long as the doctor recommends. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Skopryl plus can cause side effects, although not everybody gets them. The following terms are used to describe how often side effects are reported:

• Very common: occurs in at least 1 in 10 people
• Common: occurs in less than 1 in 10 people
• Uncommon: occurs in less than 1 in 100 people
• Rare: occurs in less than 1 in 1,000 people
• Very rare: occurs in less than 1 in 10,000 people
• Unknown: frequency cannot be estimated from the available data

The patient should stop taking the tablets and inform their doctor immediately if they experience any of the following symptoms: swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing. These may be symptoms of an allergic reaction. A severe allergic reaction (anaphylactic reaction) may also occur.

The following side effects have been observed: Common:dizziness, headache, feeling of dizziness when standing up quickly due to low blood pressure (orthostatic hypotension) that can lead to fainting; cough, diarrhea, vomiting, kidney problems. Uncommon:sensation disturbances, such as numbness and tingling, feeling of spinning, taste disturbances, mood changes, sleep disturbances, heart attack or stroke in some patients (which may be due to low blood pressure), rapid heart rate, palpitations, Raynaud's syndrome (whose symptoms include a feeling of cold in the fingers of the hands and feet), sneezing and runny nose (rhinitis), nausea, abdominal pain, indigestion, rash, itching, impotence, weakness, and fatigue, changes in laboratory blood tests. Rare:disorientation, dryness of the mucous membranes of the mouth, hives, psoriasis (skin disease), hair loss, skin redness, high levels of urea in the blood, kidney problems or kidney failure, breast enlargement in men, low levels of sodium in the blood that can cause weakness, fatigue, headache, nausea, vomiting, and painful muscle cramps. Very rare:blood disorders that can cause fever or chills, sore throat, mouth or throat ulcers, weakness, and fatigue, unusual bleeding or bruising of unknown cause; lymph node enlargement, autoimmune disease (a condition in which the immune system attacks the body), low blood sugar levels, wheezing, sinus pain, allergic pneumonia, pancreatitis, allergic reaction with swelling of the intestinal mucosa (intestinal angioedema), liver inflammation (causing nausea, fever, and dark urine), jaundice (yellowing of the skin and/or eyes), liver failure, excessive sweating, blistering, skin disorders, including redness and peeling of the skin, and painful skin areas, changes in urine output, acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion). Very rarely, it has also been reported that liver inflammation in some patients has progressed to liver failure. If the patient develops jaundice, they should immediately inform their doctor. There have been reports of a condition characterized by a group of symptoms including fever, muscle and joint pain, and blood vessel inflammation. Sun sensitivity and rash may also occur. Other side effects (frequency unknown):depression, sudden redness, pain, and swelling of the salivary glands, loss of appetite (anorexia), high blood sugar levels, presence of sugar in the urine, increased levels of uric acid in the blood, electrolyte imbalance, increased cholesterol levels in the blood, gout, restlessness, xanthopsia (color vision disturbance, in which yellow vision predominates), transient blurred vision, visual impairment or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye or acute angle-closure glaucoma), vertigo of labyrinthine origin (feeling of spinning), vasculitis, fluid accumulation in the lungs, sun sensitivity, non-melanoma skin cancer, unusual bleeding or bruising under the skin, stomach irritation, lupus-like reactions, reactivation of cutaneous lupus erythematosus (an autoimmune disease), muscle cramps, muscle weakness, interstitial nephritis (kidney inflammation), fever.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Skopryl plus

There are no special precautions for storing the medicinal product. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated. Do not use this medicine if the packaging is damaged. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Skopryl plus contains

• The active substances are lisinopril and hydrochlorothiazide. One tablet contains 20 mg of lisinopril (as lisinopril dihydrate) and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: mannitol, calcium hydrogen phosphate anhydrous, maize starch, maize starch pregelatinised, povidone (K 25), magnesium stearate, and iron oxide brown 75 (E 172) (contains iron oxide black and iron oxide red).

What Skopryl plus looks like and contents of the pack

Light brown-purple, round, biconvex tablets with a dividing line on one side. The diameter of the tablet is approximately 9 mm. The dividing line on the tablet only makes it easier to break the tablet for easier swallowing. Skopryl plus, 20 mg + 12.5 mg, tablets are available in packs of 30 tablets.

Marketing authorization holder and manufacturer

Alkaloid – INT d.o.o., Šlandrova ulica 4, 1231 Ljubljana-Črnuče, Slovenia, tel.: +386-1- 300 - 42 90, fax: +386-1- 300 - 42 91, e-mail: [email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: Skopryl plus (Скоприл плюс) 20 mg/12.5 mg tablets (таблетки)

Czech Republic: SKOPRYL PLUS H 20 mg/12,5 mg tablets

Hungary: Skopryl plus 20 mg/12,5 mg tablets

Poland: Skopryl plus

Slovenia: Skopryl HCT 20 mg/12,5 mg tablets

Romania: Skopryl Plus 20 mg/12,5 mg tablets

Date of last revision of the leaflet: 11.02.2022