Sinertec

PACKAGE LEAFLET

Package leaflet: Information for the user

Sinertec 20 mg/6 mg tablets

enalapril maleate/hydrochlorothiazide
Read 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. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Sinertec is and what it is used for

Your doctor has prescribed Sinertec for the treatment of hypertension (high blood pressure).
The active substance enalapril in Sinertec belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors, and works by dilating blood vessels to make it easier for the heart to pump blood throughout the body. The active substance hydrochlorothiazide in Sinertec belongs to a group of medicines called diuretics, and works by increasing the excretion of water and salts through the kidneys. Together, enalapril and hydrochlorothiazide help reduce high blood pressure.

2. What you should know before taking Sinertec

Do not take Sinertec:

• if you are allergic to enalapril maleate, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6)
• if you have previously experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing, during prior treatment with a medicine of the same class as this medicine (ACE inhibitors). This medicine must not be taken if such reactions have occurred without a known cause, or if you have been diagnosed with hereditary or idiopathic angioedema
• if you are allergic to any sulfonamide-derived medicines. Ask your doctor if you are unsure whether you know what sulfonamide-derived medicines are
• if you are not passing urine
• in case of severe kidney problems
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
• if you are more than 3 months pregnant. (It is also preferable to avoid using Sinertec in early pregnancy – see section Pregnancy)
• in case of severe liver problems
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin, for example in the throat) is increased

If you have any doubts about whether you should start taking this medicine, contact your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Sinertec:

• Inform your doctor of any health problems you have or have had, and of any allergies.
• If you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Sinertec, consult a doctor immediately.
• Inform your doctor if you have heart problems, blood disorders, liver problems, if you are undergoing dialysis or are being treated with diuretics, or if you have recently had excessive vomiting or diarrhea. Also inform your doctor if you are on a low-salt diet, take potassium supplements, potassium-sparing agents, potassium-containing salt substitutes, or other medicines that may increase potassium levels in the blood (e.g., heparin [a medicine used to prevent blood clots], products containing trimethoprim such as co-trimoxazole [medicines used to treat infections]), if you have diabetes or any type of kidney problems (including kidney transplant), as these conditions may lead to increased potassium levels in the blood, which can be serious. In such cases, your doctor may need to adjust the dose of Sinertex or monitor your blood potassium levels. If you have diabetes and are taking oral antidiabetic medicines or insulin, you should carefully monitor for low blood glucose levels, especially during the first month of treatment with Sinertec. Inform your doctor if you have ever had an allergic reaction with swelling of the face, lips, tongue, and/or throat, with difficulty swallowing or breathing. You should know that black patients have an increased risk of such reactions with ACE inhibitors.
• Inform your doctor if you are about to undergo LDL apheresis therapy or if you are about to undergo desensitization treatment to reduce the effects of an allergy to bee or wasp stings.
• Inform your doctor if you suffer from low blood pressure (you may notice this as dizziness or lightheadedness, especially when standing up).
• Before undergoing surgery or anesthesia (even from a dentist), inform your doctor or dentist that you are being treated with Sinertec, as a sudden drop in blood pressure may occur in association with anesthesia.
• Inform your doctor if you suffer from collagen vascular diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), if you are undergoing treatments that suppress the immune response, or if you are taking allopurinol, procainamide, or any combination of these medicines.
• Inform your doctor if you are undergoing or will undergo doping tests, as this medicine may lead to positive results in doping tests.
• You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). This medicine is not recommended during 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 taken during this period (see section Pregnancy).
• If you are taking any of the following medicines, the risk of angioedema may be increased:
  • racecadotril, a medicine used to treat diarrhea
  • medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus)
  • vildagliptin, a medicine used to treat diabetes.
• Inform your doctor before taking Sinertec if you have previously had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the

risk of certain types of non-melanoma skin and lip cancer.
Protect your skin from exposure to sunlight and UV rays while taking Sinertec.

• Inform your doctor 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 have kidney problems related to diabetes
• aliskiren.
• Inform your doctor if you experience vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur from a few hours to weeks after taking Sinertec. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing these symptoms.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes
(e.g., potassium) in your blood at regular intervals.
See also the information provided in the section “Do not take Sinertec”.
Children and adolescents
Safety and efficacy in children have not been established.
Other medicines and Sinertec
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. Your doctor may need to adjust the dose and/or take other
precautions. In general, Sinertec can be taken with other medicines. For your doctor to
prescribe the correct dose of Sinertec, it is particularly important that they know if you are
taking any of the following medicines:

• An angiotensin II receptor antagonist (AIIRA) or aliskiren (see also information in the sections “Do not take Sinertec” and “Warnings and precautions”)
• Other antihypertensives (medicines to lower blood pressure)
• Diuretics
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; heparin, a medicine used to thin the blood to prevent clotting). See also information in the section “Warnings and precautions”
• Lithium (a medicine used to treat manic-depressive psychosis or bipolar disorder)
• Tricyclic antidepressants (medicines used to treat depression)
• Antipsychotics (medicines used to treat schizophrenia)
• Sympathomimetics (medicines used in the treatment of certain heart and blood vessel diseases and some cold remedies)
• Antidiabetics (medicines used to treat diabetes)
• NSAIDs (medicines used to treat pain and arthritis, including gold therapy)
• An mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus: medicines used to treat certain types of cancer or to prevent rejection of a transplanted organ by the body’s immune system). See also information in the section “Warnings and precautions”.
• A medicine containing a neprilysin inhibitor such as sacubitril (available as a fixed-dose combination with valsartan), racecadotril, or vildagliptin. The risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing)

may be increased. See also information in the sections “Do not take
Sinertec” and “Warnings and precautions”.

• Cytostatics (medicines used in cancer therapy)

Sinertec with food and drinks
Most people take Sinertec with a glass of water.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine. Your doctor will usually advise you to stop taking Sinertec before becoming pregnant or as soon as you find out you are pregnant, and will recommend another medicine instead of Sinertec. This medicine is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to start breastfeeding. This medicine is not recommended for breastfeeding mothers.
Driving and using machines
Individual responses to medicines may vary. Some side effects reported with this medicine may affect the ability of some patients to drive or operate machinery (see Possible side effects).
Sinertec contains lactose
Sinertec contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Sinertec contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive doping test.

3. How to take Sinertec

Your doctor will decide the correct dose for you, taking into account your condition and whether you are taking other medicines.
The recommended dose is one tablet once daily. Most people take this medicine with a glass of water.
Patients with a history of kidney problems may require a lower dose of this medicine.
Previous treatment with diuretics should be discontinued 2–3 days before starting treatment with this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist. It is very important to continue taking this medicine for as long as prescribed by your doctor. Do not take more tablets than the prescribed dose.

If you take more Sinertec than you should
In case of overdose, contact your doctor immediately so that you can be medically monitored as soon as possible. The most likely symptoms are dizziness or lightheadedness due to a sudden or excessive drop in blood pressure, excessive thirst, cough, confusion, shortness of breath, anxiety, reduced urine output, or fast or slow heartbeat.

If you forget to take Sinertec
You should take this medicine as prescribed by your doctor. Do not take a double dose to make up for a forgotten tablet. Simply continue as scheduled.

If you stop taking Sinertec
Do not stop taking this medicine unless your doctor tells you to.
If you have any doubts about how to use 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 terms are used to describe how often the side effects have been reported:
Very common (affects at least 1 in 10 people treated)
Common (affects at least 1 in 100 but less than 1 in 10 people treated)
Uncommon (affects at least 1 in 1,000 but less than 1 in 100 people treated)
Rare (affects at least 1 in 10,000 but less than 1 in 1,000 people treated)
Very rare (affects less than 1 in 10,000 people treated)
Not known (frequency cannot be estimated from the available data)

Benign, malignant and unspecified tumours (including cysts and polyps)
Not known: skin and lip cancer (non-melanoma skin cancer)

Blood disorders:
Uncommon: anaemia (including aplastic and haemolytic anaemia)
Rare: changes in blood values such as decreased number of white and red blood cells, decreased haemoglobin, decreased platelet count, swelling of glands in the neck, armpits or groin.

Endocrine disorders:
Not known: excessive production of antidiuretic hormone, causing fluid retention, which may lead to weakness, fatigue or confusion.

Metabolism and nutrition disorders:
Common: low blood potassium levels, increased cholesterol or blood fats, high blood uric acid levels.
Uncommon: low blood sugar levels (hypoglycaemia), low blood magnesium levels (hypomagnesaemia), joint pain and swelling caused by uric acid crystals (gout).
Rare: increased blood sugar levels.
Very rare: high blood calcium levels (hypercalcaemia).

Nervous system disorders:
Common: headache, depression, fainting (syncope), altered taste.
Uncommon: confusion, drowsiness, insomnia, nervousness, tingling without cause (paraesthesia), sensations of dizziness, decreased libido.
Rare: unusual dreams, sleep disturbances, muscle weakness sometimes due to low potassium levels (paresis).

Eye disorders:
Very common: blurred vision
Not known: reduced vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion)).

Ear disorders:
Uncommon: ringing in the ears.

Cardiac and vascular disorders:
Very common: dizziness.
Common: lightheadedness due to low blood pressure (including sudden drop in blood pressure when standing up quickly), angina or chest pain, changes in heart rhythm, fast heartbeat.
Uncommon: hot flushes, rapid or irregular heartbeat (palpitations), heart attack, stroke possibly due to excessively low blood pressure in high-risk patients (patients with heart and/or brain blood flow disorders).
Rare: poor blood circulation in limbs (Raynaud's phenomenon).

Respiratory disorders:
Very common: cough.
Common: shortness of breath.
Uncommon: runny nose, sore throat and hoarseness, asthma associated with chest tightness.
Rare: nasal inflammation, accumulation of fluid or other substances in the lungs (shown on X-ray), breathing difficulty, respiratory distress (including pneumonia, pulmonary oedema, allergic alveolitis/eosinophilic pneumonia).
Very rare: Acute respiratory distress (symptoms include severe shortness of breath, fever, weakness and confusion).

Gastrointestinal disorders:
Very common: nausea.
Common: diarrhoea, abdominal pain.
Uncommon: slow movement of food through the intestine (ileus), inflammation of the pancreas (pancreatitis), vomiting, indigestion (dyspepsia), constipation, loss of appetite, stomach irritation and pain, dry mouth, stomach peptic ulcer, excess gas in the stomach or intestine.
Rare: mouth ulcers (stomatitis/aphthous ulceration), swelling of the tongue (glossitis).
Very rare: intestinal swelling (intestinal angioedema).

Hepatobiliary and biliary disorders:
Rare: inflammation of the liver (hepatitis), liver failure which may be fatal, yellowing of the eyes or skin (jaundice), gallbladder problems.

Skin disorders:
Common: skin rash, allergic reactions with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing.
Uncommon: increased sweating (diaphoresis), itching, hives, hair loss (alopecia).
Rare: severe hypersensitivity reaction with high fever, target-shaped skin rash (erythema multiforme), Stevens-Johnson syndrome and toxic epidermal necrolysis (serious skin conditions with redness, peeling and blistering of the skin), severe skin rash with loss of skin and hair (exfoliative dermatitis), cutaneous lupus erythematosus (an immune disease), red rash with skin peeling (erythroderma), appearance of small fluid-filled blisters on the skin (pemphigus), purple or red spots on the skin (purpura).
Not known: a symptomatic complex has been reported which may include some or all of the following: fever, inflammation of blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Skin rash, sensitivity to sunlight or other skin manifestations may also occur.

Musculoskeletal, connective tissue and bone disorders:
Common: muscle cramps.
Uncommon: joint pain.

Renal and urinary disorders:
Uncommon: kidney problems (renal dysfunction), kidney failure, presence of protein in urine (proteinuria).
Rare: decreased urine output (oliguria), kidney disease (interstitial nephritis).

Reproductive system and breast disorders:
Uncommon: impotence.
Rare: breast enlargement in men (gynaecomastia).

General disorders:
Very common: weakness.
Common: chest pain, fatigue.
Uncommon: feeling unwell, fever.

Laboratory tests:
Common: increased blood potassium levels, increased blood creatinine levels.
Uncommon: high blood urea levels, low blood sodium levels.
Rare: high levels of liver enzymes or bilirubin.

Other side effects may also occur with uncommon or rare frequency, and some of them may be serious. Ask your doctor or pharmacist for more information about side effects. Both have a more complete list of side effects.
Tell your doctor or pharmacist immediately if you experience any of these or any other unusual symptoms.
Stop taking Sinertec and contact your doctor immediately if any of the following occur:

• if you experience swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing
• if you experience swelling of the hands, feet or ankles
• if you develop hives.

The initial dose may cause a greater drop in blood pressure than will occur during continued treatment.
This may present as fainting or dizziness, and lying down may help. If you are concerned, contact your doctor.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

Observed only with hydrochlorothiazide doses of 12.5 mg and 25 mg.
The frequency of muscle cramps defined as common refers to hydrochlorothiazide doses of 12.5 mg and 25 mg, whereas the frequency of this event is defined as uncommon when referring to the 6 mg hydrochlorothiazide dose.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Sinertec

Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
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 Sinertec contains

• The active substances are enalapril maleate (20 mg) and hydrochlorothiazide (6 mg);
• The other components are sodium bicarbonate, lactose monohydrate, maize starch, pregelatinized starch, indigotine (E132), magnesium stearate.

Sinertec is available in packs containing 14 tablets.
Description of the appearance of Sinertec and the contents of the pack
Sinertec tablets are blue, rounded-edge, triangular-shaped tablets, with "MSD 734" engraved on one side and a triangle on the other.
Aluminum blisters with PVC laminate containing 10, 14, 28, 30, 50, 56, 98, 100 or 300 tablets.
Single-dose aluminum blisters containing 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome
Italy
Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
This medicinal product is authorized in the European Economic Area countries under the
following names:
Austria – RENITEC PLUS
Denmark – SYNERPRIL
Italy – SINERTEC
The Netherlands – RENITEC PLUS
Spain – RENITECMAX