CONDIUREN 20 mg /12.5 Mg Tablets

Зміст інструкції

1. CONDIUREN 20 mg + 12,5 mg tablets
   1. What is Condiuren and what it is used for
   2. What you need to know before taking Condiuren
   3. How to take Condiuren
   4. Possible side effects
   5. How to store Condiuren
   6. Package contents and other information

CONDIUREN 20 mg + 12,5 mg tablets

Enalapril maleate + Hydrochlorothiazide
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. Do not pass it on to others, even if they have the same symptoms as you, as it may 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 Condiuren is and what it is used for
• 2. What you need to know before you take Condiuren
• 3. How to take Condiuren
• 4. Possible side effects
• 5. How to store Condiuren
• 6. Contents of the pack and other information

1. What is Condiuren and what it is used for

Condiuren contains the active ingredients: enalapril and hydrochlorothiazide.

• Enalapril belongs to a group of medicines called “ACE inhibitors” (Angiotensin Converting Enzyme Inhibitors), which work by reducing blood pressure by dilating blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called diuretics, which work by increasing the amount of urine produced by the kidneys.

Condiuren is used for the treatment of high blood pressure (hypertension) in adults,
when it is not possible to control it with enalapril or hydrochlorothiazide when administered alone.
Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Condiuren

Do not take Condiuren

• if you are allergic to the active ingredients (enalapril maleate or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6));
• if you have severe kidney problems (severe renal insufficiency);
• if you are unable to urinate;
• if you have previously experienced swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema) caused by a previous treatment with ACE inhibitors;
• if other people in your family have had angioedema, as there may be a familial predisposition (hereditary angioedema);
• if you suffer from idiopathic angioedema (without an obvious cause);
• if you are allergic to sulfonamide derivatives (a class of antibiotics);
• if you are pregnant for more than 3 months (see section “Pregnancy and breastfeeding”);
• if you have severe liver problems (severe hepatic insufficiency);
• 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking Condiuren:

• if during treatment your blood pressure becomes too low (hypotension), if you are at risk of excessive drop in blood pressure due to excessive loss of salts or body fluids (due to a state of illness such as vomiting, diarrhea or following a low-salt diet or due to the use of oral diuretics for a long time). Low blood pressure for a short period of time does not constitute a contraindication to continuing therapy;
• if you suffer from ischemic heart or cerebrovascular diseases. In these cases, excessive hypotension can cause myocardial infarction or stroke;
• if your kidney function is impaired. Your doctor will monitor your nitrogen and creatinine levels in the blood;
• if you have heart problems (heart failure);
• if you have been told by a doctor that you have a narrowing of the valves of your left ventricle or if you have other obstacles to the flow of the left ventricle;
• if you have an increase in the thickness of the heart muscle (known as hypertrophic cardiomyopathy);
• if you have been told by a doctor that you have a narrowing of the arteries of one or both kidneys
• if you have recently undergone a kidney transplant;
• if you need hemodialysis (blood purification by filtration) with particular membranes, as there may be reactions to the type of membrane used
• if you have liver problems;
• if there is a decrease in the number of certain types of white blood cells (neutropenia, agranulocytosis) (see section “Possible side effects”);
• if the number of red blood cells (anemia) and platelets (thrombocytopenia) decreases;
• if a doctor has told you that you suffer from a certain disease of the connective tissue (collagenopathy) with involvement of the blood vessels;
• if you are being treated with medicines that reduce your immune response (see section “Other medicines and Condiuren”);
• if you are taking allopurinol (medicine for the treatment of gout) or procainamide (medicine for the treatment of heart rhythm disorders) (see section “Other medicines and Condiuren”);
• if you are at risk of increased potassium levels in the blood;
• if you have abnormal levels of water and mineral salts in the body (hypokalemia, hyponatremia, hypochloremic alkalosis, hypomagnesemia and hypercalcemia);
• if you suffer from diabetes (high blood sugar levels) and are taking antidiabetic medicines, including insulin to control diabetes (you should undergo blood tests to check

any low blood sugar levels, especially during the first month of treatment)
(see section “Other medicines and Condiuren”);

• if you experience allergic reactions with symptoms such as swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing (angioedema) (see section “Possible side effects”);
• if you have undergone, or are about to undergo, a desensitization therapy for allergy to bee or wasp stings;
• if you have undergone, or are about to undergo, a therapy for separating the components of the blood to remove cholesterol from the blood by means of a machine (LDL apheresis);
• if you suffer from a dry and persistent cough;
• if you are about to undergo general anesthesia for a surgical operation (see section “Other medicines and Condiuren”);
• if you have problems with gout (a disease that causes joint pain), if you have high levels of uric acid in the blood;
• if you are taking lithium, used to treat certain psychiatric illnesses;
• if you are taking one of the following medicines used to treat high blood pressure:
• a. an “angiotensin II receptor blocker” (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes,
• b. aliskiren.
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Condiuren;
• if you have blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a few hours to weeks after taking Condiuren. If left untreated, this increase can lead to permanent vision loss. If you have had an allergy to penicillins or sulfonamides in the past, you may be at greater risk of developing this disorder;
• if you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking CONDIUREN, consult a doctor immediately.

The doctor may check your kidney function, blood pressure, and the amount of electrolytes (such as potassium) in your blood at regular intervals. See also what is reported in the section “Do not take Condiuren”.
As with other drugs used to lower blood pressure, this medicine may be
less effective in black patients.
.

Children and adolescents
The safety and efficacy of Condiuren in children and adolescents has notbeen established, therefore this
medicine is not recommended for children and adolescents.

Other medicines and Condiuren
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular, before starting treatment with Condiuren, tell your doctor if you are taking:

• other medicines that lower blood pressure (antihypertensives), including vasodilators, nitroglycerin and other nitrates, beta-blockers;
• lithium (medicine used for certain psychiatric problems);
• non-steroidal anti-inflammatory medicines (NSAIDs) often used as painkillers or to reduce inflammation;
• other diuretics, especially diuretics called “potassium-sparing” (e.g. spironolactone, triamterene or amiloride), loop diuretics (e.g. furosemide) and thiazide diuretics;
• potassium supplements or salt substitutes containing potassium;
• medicines used to treat mental illnesses (antipsychotic medicines) or to treat depression (tricyclic antidepressants);
• anesthetics;
• sympathomimetics (medicines with a stimulating effect used for example to treat asthma);
• medicines to treat diabetes, including insulin and oral medicines to lower blood sugar levels;
• medicines to make the blood more fluid (such as thrombolytics and acetylsalicylic acid at cardiac dosages);
• injectable gold (medicine used to treat rheumatoid arthritis, a chronic inflammation of the joints);
• muscle relaxants (medicines administered during surgical operations);
• barbiturates and narcotics (substances that reduce brain activity);
• cholestyramine and colestipol, resins (medicines used to lower cholesterol levels in the blood);
• medicines for the heart (antiarrhythmics, such as procainamide, quinidine, amiodarone, sotalol);
• corticosteroids or corticotropin (ACTH) to treat inflammation such as rheumatism;
• carbenoxolone (another medicine to treat inflammation of the intestinal tract);
• laxatives, especially if taken in excessive doses;
• pressor amines (medicines with potent stimulating effects such as norepinephrine);
• cytostatic agents, medicines used to reduce the growth of tumors (e.g. cyclophosphamide, methotrexate);
• allopurinol (for the treatment of gout, a disease that causes joint pain);
• medicines that reduce the immune response.

The doctor may need to adjust the dose and/or take other precautions:

• if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is reported in the section “Do not take Condiuren” and “Warnings and precautions”).

Condiuren with food, drinks and alcohol
Consult your doctor before using food supplements or salt substitutes containing potassium.
The use of alcohol together with Condiuren may cause an excessive decrease in blood pressure.

Pregnancy and breastfeeding
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 taking this medicine.

Pregnancy
The use of Condiuren is not recommendedduring the first 3 months of pregnancy.
The use of Condiuren is contraindicatedafter the first 3 months of pregnancy (see section “Do not take
Condiuren”).
As a rule, your doctor will advise you to stop taking Condiuren before starting
pregnancy or as soon as you are diagnosed with a pregnancy and will advise you to take another
medicine. Condiuren is not recommended in early pregnancy, and should not be taken after
the third month of pregnancy as it can cause serious harm to the baby (see section
“Do not take Condiuren”).
Do not make decisions about stopping or continuing therapy without consulting your
doctor.
If you were to take Condiuren after 3 months of pregnancy, the doctor will monitor the fetus through a
ultrasound scan to assess kidney and skull function and then the newborn to check
hypotension (see section “Do not take Condiuren”).
Condiuren should not be used for the treatment of gestational edema (swelling during
pregnancy generally of the ankles, feet, hands, legs), gestational hypertension (increased
pressure during pregnancy) or preeclampsia (syndrome characterized by the presence, single or in
association, of clinical signs such as edema, proteinuria or hypertension .

Breastfeeding
Condiuren passes into breast milk in small amounts, so it is not recommended during breastfeeding. If
the doctor deems treatment with Condiuren necessary during breastfeeding, the prescribed doses
will be the lowest possible as high doses cause intense diuresis which can inhibit milk production.
.

Driving and using machines
During treatment with Condiuren you may experience dizziness or fatigue.
Therefore, avoiddriving vehicles or using machinery that requires particular attention if you notice any of
these symptoms.

Condiuren contains lactose:
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine;
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e.
essentially ‘sodium-free’.
For those who play sports
The use of the drug without therapeutic need constitutes doping and may still result in positive
doping tests.
Consult your doctor if you are an athlete and need to undergo a doping test.

3. How to take Condiuren

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Adults
The initial dose is half a tablet a day.
The recommended dose is 1 tablet once a day. In general, your doctor may increase the
dosage up to 2 tablets to be taken simultaneously in a single daily dose.
If you are already being treated with diuretics (medicines that increase urine output), therapy with
Condiuren may cause severe hypotension.
In such cases, your doctor will discontinue the diuretic therapy a few days before starting therapy
with Condiuren. If this is not possible, your doctor will start treatment with enalapril alone at a dose
of 2.5 mg.

Patients with reduced kidney function (renal insufficiency)
If you suffer from renal insufficiency, your doctor, after assessing your kidney function, may not
prescribe Condiuren as this medicine may be ineffective in cases of moderate or severe
renal insufficiency.
In cases of mild renal insufficiency, the dosage of Condiuren must be carefully evaluated by
your doctor. When used alone, the recommended initial dose of enalapril should be 5-10 mg.

Use in children and adolescents
The safety and efficacy of Condiuren in children and adolescents has notbeen established, therefore this
medicine is not recommended for children and adolescents.

Use in the elderly
The efficacy and tolerability of enalapril maleate and hydrochlorothiazide, administered in combination,
have been similar in elderly and younger patients.

Method of administration
Take the tablets with a little water, at about the same time each day.

If you take more Condiuren than you should
If you have taken too many tablets, contact your doctor or go to hospital immediately. Symptoms of
overdose may include:

• a significant drop in blood pressure with severe impairment of consciousness
• dizziness
• excessive increase or excessive decrease in heart rate
• alteration of electrolytes in the blood and dehydration
• renal insufficiency
• vertigo
• palpitation (sensation that the heartbeat is abnormally fast and irregular)
• rapid breathing
• anxiety
• cough Your doctor or hospital staff will monitor you closely and adopt specific therapies.

If you forget to take Condiuren
Do not take a double dose to make up for a missed tablet.

If you stop taking Condiuren
Do not stop treatment without first consulting your doctor.
If you have any questions 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.
If you experience any of the following side effects during treatment with Condiuren, with the frequencies
listed below, contact your doctor immediately:

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

• blurred vision
• dizziness
• cough
• nausea
• asthenia (general weakness)

Common (may affect up to 1 in 10 people):

• reduction of potassium levels in the blood (hypokalaemia)
• increased cholesterol in the blood
• increased triglycerides (fatty acids) in the blood
• increased uric acid levels in the blood (hyperuricaemia)
• headache
• depression
• syncope (fainting)
• alterations of the sense of taste
• reduced blood pressure (hypotension)
• orthostatic hypotension (reduction of blood pressure when reaching an upright position accompanied by symptoms such as dizziness/lightheadedness)
• alterations of heart rhythm
• angina pectoris (chest pain due to lack of blood, therefore oxygen supply to the heart)
• tachycardia (increased heart rate per minute)
• dyspnoea (shortness of breath)
• diarrhoea
• abdominal pain
• skin rash with pustules, blisters and bubbles (exanthema), hypersensitivity/angioedema (swelling of the face, tongue or throat, difficulty swallowing, urticaria and difficulty breathing)
• muscle cramps
• chest pain
• fatigue
• alterations in blood tests to check kidney function (increased creatinine)
• increased potassium levels in the blood (hyperkalaemia)

Uncommon (may affect up to 1 in 100 people):

• anaemia (reduction of haemoglobin), including aplastic anaemia (insufficient production of all types of blood cells by the bone marrow) and haemolytic anaemia (disease due to the destruction of red blood cells)
• decreased blood sugar levels (hypoglycaemia)
• hypomagnesaemia (decrease in the amount of magnesium in the blood)
• gout (disease that causes pain and swelling of the joints)
• confusion
• drowsiness
• insomnia
• nervousness
• paresthesia (tingling)
• vertigo
• decreased sexual desire (decreased libido)
• hearing disorders (tinnitus)
• hot flushes
• palpitations (sensation of increased heartbeats)
• heart attack (myocardial infarction) and/or stroke (cerebrovascular event), possibly as a result of excessive reduction of blood pressure
• runny nose (rhinorrhea)
• sore throat and hoarseness
• bronchospasm (severe difficulty breathing), asthma
• reduced bowel movements (ileus)
• pancreatitis (inflammation of the pancreas)
• vomiting and/or dyspepsia (indigestion)
• constipation
• anorexia (loss of appetite)
• stomach irritation and/or peptic ulcer (gastric or duodenal)
• dry mouth
• flatulence
• diaphoresis (abnormal sweating)
• pruritus (itching)
• urticaria (skin redness accompanied by itching)
• hair loss (alopecia)
• joint pain (arthralgia)
• alteration of kidney function or kidney failure
• presence of protein in the urine (proteinuria)
• impotence
• feeling unwell
• fever
• increased nitrogen levels in urine
• decreased sodium levels in the blood (hyponatraemia)

Rare (may affect up to 1 in 1000 people):

• decrease of a certain type of white blood cells (neutropenia)
• decrease in haemoglobin in the blood
• reduction of the total volume of red blood cells (low haematocrit)
• reduction in the number of platelets in the blood (thrombocytopenia)
• increased number of granulocytes in the blood, a type of blood cell (agranulocytosis)
• bone marrow depression (insufficient production of blood cells)
• leucopenia (reduction in the number of white blood cells in the blood)
• decrease of all different types of cells in the blood (pancytopenia)
• swelling of the glands (lymphadenopathy)
• autoimmune diseases (diseases in which the immune system reacts against the body)
• increased blood sugars
• abnormal dreams and/or sleep disorders
• inability to move (paresis) due to low potassium levels in the blood
• Raynaud's phenomenon (pain in the fingers of hands and feet that first become white, then bluish and finally reddish)
• radiological alterations of the lungs (pulmonary infiltrates)
• serious problems with the lungs (including inflammation and fluid accumulation in the lungs)
• inflammation of the nose (rhinitis)
• allergic reaction in the lungs (allergic alveolitis) or eosinophilic pneumonia (a lung disease)
• inflammation of the mucous membrane lining (stomatitis) or ulcerations of the oral cavity
• inflammation of the tongue (glossitis)
• liver failure (serious liver disease)
• hepatic necrosis (liver damage potentially fatal)
• hepatitis (inflammation of the liver)
• jaundice (yellowing of the skin and whites of the eyes)
• inflammation of the gallbladder (especially in patients with pre-existing gallstones)
• erythema multiforme (skin inflammation)
• Stevens-Johnson syndrome and toxic epidermal necrolysis (severe skin injury characterized by skin irritation, blistering lesions with areas of skin detachment)
• exfoliative dermatitis (skin irritation with scaling of the skin)
• purpura (disease in which the skin takes on a reddish color due to abnormal accumulation of blood)
• cutaneous lupus erythematosus (immune system disease that manifests with skin rashes, swelling, redness)
• erythrodermia (redness of the skin)
• pemphigus (blistering skin disease)
• oliguria (reduced amount of urine)
• interstitial nephritis (kidney diseases)
• gynaecomastia (growth of the breast in men)
• increased liver enzymes
• increased bilirubin (a substance produced by the body whose increase may be due to a liver disorder) in the blood

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

• hypercalcemia (increased amount of calcium in the blood)
• intestinal angioedema (swelling of the intestinal walls that can cause severe abdominal pain, with vomiting and diarrhoea)
• acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Not known (frequency cannot be estimated from available data):

• inadequate production of the antidiuretic hormone (SIADH) which reduces, among other things, the amount of urine
• Skin and lip cancer (non-melanoma skin cancer).
• Rapid onset of distant vision impairment (acute myopia), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion), or acute angle-closure glaucoma.

Other side effects
A group of symptoms including some or all of the following have also been reported: fever,
serositis (inflammation of the membranes lining the body cavities, such as chest and abdomen),
vasculitis (inflammation of blood vessels), muscle pain or muscle inflammation, pain or
inflammation of the joints, alterations in blood tests (positive ANA antibodies, increased
erythrocyte sedimentation rate ([ESR]), increase in the number of white blood cells (eosinophilia,
leukocytosis), skin rash, skin sensitivity to light (photosensitivity) and other skin problems.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 Condiuren

Keep this medicine out of the sight and reach of children.
This medicine does not require special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after Scad. The expiry date refers to the last day of that month.
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. Package contents and other information

• the active substances are: enalapril maleate (each tablet contains 20 mg enalapril maleate), hydrochlorothiazide (each tablet contains 12.5 mg of hydrochlorothiazide).
• the other ingredients are: sodium bicarbonate, lactose monohydrate(see section 2 “Condiuren contains lactose”), yellow iron oxide, corn starch, pregelatinized starch, magnesium stearate. Description of the appearance of Condiuren and package contentsTablets packaged in aluminum blisters of 14 tablets and 28 tablets. Not all pack sizes may be available.

Marketing Authorisation Holder
Teofarma S.r.l.
Via F.lli Cervi, 8 – 27010 Valle Salimbene (PV)
Fax 0382/525845
e-mail: [email protected]

Manufacturer
DOPPEL FARMACEUTICI S.r.l
Via Volturno, 48 – Quinto dè Stampi
20089 Rozzano (Milano)