Condiuren

Patient Information Leaflet

CONDIUREN 20 mg + 12.5 mg tablets

Enalapril maleate + Hydrochlorothiazide
Please read all of this leaflet carefully before you start 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 give it to other people, even if they have the same symptoms as you, because it may 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 Condiuren is 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. Contents of the pack and other information

1. What Condiuren is and what it is used for

Condiuren contains the active substances: enalapril and hydrochlorothiazide.

• Enalapril belongs to a group of medicines called “ACE inhibitors” (Angiotensin Converting Enzyme inhibitors), which work by reducing blood pressure through widening of the 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 cannot be controlled with enalapril or hydrochlorothiazide given alone.
Talk to your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Condiuren

Do not take Condiuren

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

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

• if during treatment your blood pressure becomes too low (hypotension), especially if you are at risk of excessive drop in blood pressure due to significant loss of body salts or fluids (due to illness such as vomiting, diarrhoea, or following a low-salt diet or prolonged use of oral diuretics). A brief period of low blood pressure does not constitute a contraindication to continuing therapy;
• if you suffer from ischemic heart disease or cerebrovascular disease. In such cases, excessive hypotension may lead to myocardial infarction or stroke;
• if your kidney function is impaired. Your doctor will monitor your blood levels of nitrogen and creatinine;
• if you have heart problems (heart failure);
• if a doctor has told you that you have narrowing of the heart valves of your left ventricle or other obstructions to left ventricular outflow;
• if you have thickening of the heart muscle (known as hypertrophic cardiomyopathy);
• if a doctor has told you that you have narrowing of the artery or arteries supplying one or both kidneys;
• if you have recently undergone kidney transplantation;
• if you require haemodialysis (blood purification by filtration) with certain types of membranes, as reactions to the type of membrane used may occur;
• 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 there is a reduction in red blood cells (anaemia) and platelets (thrombocytopenia);
• if a doctor has told you that you suffer from a connective tissue disease (collagenosis) involving 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 (a medicine for the treatment of gout) or procainamide (a medicine for the treatment of cardiac 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 electrolytes in the body (hypokalaemia, hyponatraemia, hypochloraemic alkalosis, hypomagnesaemia and hypercalcaemia);
• if you suffer from diabetes (high blood sugar levels) and are taking antidiabetic medicines, including insulin to control diabetes (you should have blood tests to monitor for possible low blood glucose levels, especially during the first month of treatment) (see section “Other medicines and Condiuren”);
• if you develop allergic reactions with symptoms such as swelling of the face, tongue or throat, difficulty swallowing, hives and breathing difficulties (angioedema) (see section “Possible side effects”);
• if you have undergone, or are about to undergo, desensitisation therapy for allergy to bee or wasp stings;
• if you have undergone, or are about to undergo, a procedure to separate blood components to remove cholesterol from the blood using a machine (LDL apheresis);
• if you suffer from a persistent dry cough;
• if you are about to undergo general anaesthesia for surgery (see section “Other medicines and Condiuren”);
• if you suffer from gout (a disease causing joint pain) or have high levels of uric acid in the blood;
• if you are taking lithium, used to treat certain psychiatric disorders;
• if you are taking any of the following medicines used to treat high blood pressure: a. an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes, b. aliskiren;
• if you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV rays while taking Condiuren;
• if you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur from a few hours to weeks after taking Condiuren. If untreated, this increase may lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this condition;
• if you have had respiratory or lung problems (including inflammation or fluid in the lungs) following previous use of hydrochlorothiazide. If shortness of breath or severe breathing difficulties occur after taking CONDIUREN, consult a doctor immediately.

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 under “Do not take Condiuren”.
As with other medicines 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 not been established, therefore this medicine is not recommended for children and adolescents.

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

• other medicines that lower blood pressure (antihypertensives), including vasodilators, nitroglycerin and other nitrates, beta-blockers;
• lithium (a medicine used for certain psychiatric conditions);
• non-steroidal anti-inflammatory drugs (NSAIDs), often used as painkillers or to reduce inflammation;
• other diuretic medicines, especially potassium-sparing diuretics (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 (antipsychotics) or depression (tricyclic antidepressants);
• anaesthetics;
• sympathomimetics (stimulant medicines used, for example, to treat asthma);
• medicines for treating diabetes, including insulin and oral medicines to reduce blood sugar levels;
• medicines to make the blood thinner (such as thrombolytics and cardiac-dose acetylsalicylic acid);
• injectable gold (a 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 treating irregular heartbeat (antiarrhythmics, such as procainamide, quinidine, amiodarone, sotalol);
• heart medicines (cardiac glycosides, such as digoxin, which increase the force of heart contraction);
• corticosteroids or corticotropin (ACTH) used to treat inflammation such as rheumatism;
• carbenoxolone (another medicine used to treat intestinal tract inflammation);
• laxatives, especially if taken in excessive doses;
• pressor amines (medicines with strong stimulant effects such as noradrenaline);
• cytostatic agents, medicines used to reduce tumour growth (e.g. cyclophosphamide, methotrexate);
• allopurinol (for the treatment of gout, a disease causing joint pain);
• medicines that reduce the immune response.

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 information under “Do not take Condiuren” and “Warnings and precautions”).

Condiuren with food, drinks and alcohol
Consult your doctor before using dietary supplements or salt substitutes containing potassium.
Drinking alcohol together with Condiuren may cause an excessive drop in blood pressure.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The use of Condiuren is not recommended during the first 3 months of pregnancy.
The use of Condiuren is contraindicated after the first 3 months of pregnancy (see section “Do not take Condiuren”).
Your doctor will normally advise you to stop taking Condiuren before becoming pregnant or as soon as pregnancy is diagnosed, and will recommend an alternative medicine. Condiuren is not recommended during early pregnancy and must not be taken after the third month of pregnancy because it may cause serious harm to the unborn child (see section “Do not take Condiuren”).
Do not make decisions about stopping or continuing treatment without consulting your doctor.
If you take Condiuren after the third month of pregnancy, your doctor will monitor the foetus with ultrasound to assess kidney and skull function, and the newborn will be monitored for hypotension (see section “Do not take Condiuren”).
Condiuren must not be used to treat gestational oedema (swelling during pregnancy, usually in the ankles, feet, hands, legs), gestational hypertension (high blood pressure during pregnancy), or pre-eclampsia (a syndrome characterised by the presence, alone or in combination, of clinical signs such as oedema, proteinuria or hypertension).

Breastfeeding
Condiuren passes into breast milk in small amounts and is therefore not recommended during breastfeeding. If your doctor considers treatment with Condiuren necessary during breastfeeding, the prescribed doses will be as low as possible, since high doses cause intense diuresis which may inhibit milk production.

Driving and using machines
During treatment with Condiuren, you may experience dizziness or fatigue.
Therefore, avoid driving or operating machinery requiring special attention if you experience any of these symptoms.

Condiuren contains lactose:
If your doctor has diagnosed you with an 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 athletes
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Consult your doctor if you are an athlete and are required to undergo an anti-doping test.

3. How to take Condiuren

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
The initial dose is half a tablet per day.
The recommended dose is 1 tablet once daily. In general, your doctor may increase the
dosage up to 2 tablets taken together as a single daily dose.
If you are already being treated with diuretics (medicines that increase urine elimination), therapy with
Condiuren may cause severe hypotension.
In such cases, your doctor will discontinue your diuretic treatment for a few days before starting
Condiuren therapy. If this is not possible, your doctor will initiate treatment with enalapril alone at a dose
of 2.5 mg.
Patients with reduced kidney function (renal impairment)
If you suffer from renal impairment, your doctor, after assessing your kidney function, may decide not
to prescribe Condiuren, as this medicine may be ineffective in cases of moderate or severe renal impairment.
In cases of mild renal impairment, 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 not been established, therefore this
medicine is not recommended for use in children and adolescents.
Use in the elderly
The efficacy and tolerability of enalapril maleate and hydrochlorothiazide, when administered together,
have been similar in elderly patients and younger patients.
Method of administration
Take the tablets with a little water, approximately at 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 marked drop in blood pressure with severe impairment of consciousness
• dizziness
• excessive increase or excessive decrease in heart rate
• disturbances in blood electrolytes and dehydration
• renal failure
• dizziness
• palpitations (sensation of abnormally rapid and irregular heartbeat)
• rapid breathing
• anxiety
• cough

Your doctor or hospital staff will closely monitor you and initiate appropriate treatments.

If you forget to take Condiuren
Do not take a double dose to make up for the 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, consult 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 side effects listed below during treatment with Condiuren, 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 in blood potassium levels (hypokalaemia)
• increased blood cholesterol
• increased blood triglycerides (fatty acids)
• increased blood uric acid levels (hyperuricaemia)
• headache
• depression
• syncope (fainting)
• altered taste sensation
• reduction in blood pressure (hypotension)
• orthostatic hypotension (reduction in blood pressure upon standing, accompanied by symptoms such as dizziness/light-headedness)
• changes in heart rhythm
• angina pectoris (chest pain due to insufficient blood supply, hence oxygen, to the heart)
• tachycardia (increased heart rate)
• dyspnoea (shortness of breath)
• diarrhoea
• abdominal pain
• skin rash with pustules, blisters and bullae (exanthema), hypersensitivity/angioedema (swelling of face, tongue or throat, difficulty swallowing, urticaria and breathing difficulties)
• muscle cramps
• chest pain
• fatigue
• abnormalities in blood tests assessing kidney function (increased creatinine)
• increased blood potassium levels (hyperkalaemia)

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

• anaemia (reduced haemoglobin), including aplastic anaemia (inadequate production of all types of blood cells by the bone marrow) and haemolytic anaemia (disease due to destruction of red blood cells)
• decreased blood sugar levels (hypoglycaemia)
• hypomagnesaemia (reduced magnesium levels in blood)
• gout (disease causing pain and swelling in joints)
• confusion
• somnolence (drowsiness)
• insomnia
• nervousness
• paraesthesia (tingling)
• vertigo
• decreased sexual desire (reduced libido)
• hearing disorders (tinnitus)
• hot flushes
• palpitations (awareness of increased heartbeat)
• heart attack (myocardial infarction) and/or stroke (cerebrovascular event), possibly as a consequence of excessive reduction in blood pressure
• runny nose (rhinorrhoea)
• sore throat and hoarseness
• bronchospasm (severe breathing difficulty), asthma
• reduced intestinal motility (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 (red, itchy skin rashes)
• hair loss (alopecia)
• joint pain (arthralgia)
• impaired kidney function or kidney failure
• presence of protein in urine (proteinuria)
• impotence
• malaise
• fever
• increased nitrogen levels in urine
• decreased blood sodium levels (hyponatraemia)

Rare (may affect up to 1 in 1,000 people):

• reduction in a certain type of white blood cells (neutropenia)
• decreased haemoglobin in blood
• reduced total volume of red blood cells (low haematocrit)
• reduced number of platelets in blood (thrombocytopenia)
• increased number of granulocytes in blood, a type of blood cell (agranulocytosis)
• bone marrow suppression (inadequate production of blood cells)
• leucopenia (reduced number of white blood cells)
• reduction in all types of blood cells (pancytopenia)
• swelling of glands (lymphadenopathy)
• autoimmune diseases (conditions in which the immune system attacks the body)
• increased blood glucose levels
• abnormal dreams and/or sleep disturbances
• inability to move (paresis) due to low blood potassium levels
• Raynaud's phenomenon (pain in fingers of hands and feet turning first pale, then bluish, and finally reddish)
• radiological lung abnormalities (pulmonary infiltrates)
• severe lung problems (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 mucosal lining (stomatitis) or oral ulceration
• inflammation of the tongue (glossitis)
• liver failure (severe liver disease)
• hepatic necrosis (potentially fatal liver damage)
• hepatitis (liver inflammation)
• jaundice (yellowing of the skin and whites of the eyes)
• inflammation of the gallbladder (particularly in patients with pre-existing gallstones)
• erythema multiforme (skin inflammation)
• Stevens-Johnson syndrome and toxic epidermal necrolysis (severe skin lesions characterized by skin irritation, blistering and areas of skin detachment)
• exfoliative dermatitis (skin irritation with skin peeling)
• purpura (a condition where the skin turns red due to abnormal blood accumulation)
• cutaneous lupus erythematosus (an immune system disease manifesting with skin rashes, swelling, redness)
• erythroderma (redness of the skin)
• pemphigus (blistering skin disease)
• oliguria (reduced urine output)
• interstitial nephritis (kidney diseases)
• gynaecomastia (breast enlargement in men)
• increased liver enzymes
• increased bilirubin (a substance produced by the body, whose increase may be due to liver disorder) in blood

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

• hypercalcaemia (increased calcium levels in blood)
• intestinal angioedema (swelling of intestinal walls which may cause severe abdominal pain, 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 antidiuretic hormone (SIADH), which reduces, among other effects, urine output
• Skin and lip cancer (non-melanoma skin cancer)
• Sudden-onset reduction in distance vision (acute myopia), decreased vision or eye pain due to elevated 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 has also been reported, including some or all of the following: fever,
serositis (inflammation of the membranes lining body cavities such as chest and abdomen),
vasculitis (inflammation of blood vessels), muscle pain or muscle inflammation, joint pain or
joint inflammation, changes in blood tests (positive ANA antibodies, increased erythrocyte sedimentation rate ([ESR]), increased white blood cell count (eosinophilia, leucocytosis)), skin rash, skin sensitivity to light (photosensitivity) and other skin problems.

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 Condiuren

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine 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

• The active substances are: enalapril maleate (each tablet contains 20 mg enalapril maleate), hydrochlorothiazide (each tablet contains 12.5 mg hydrochlorothiazide).
• The other components are: sodium bicarbonate, lactose monohydrate (see section 2 “Condiuren contains lactose”), yellow iron oxide, maize starch, pregelatinized starch, magnesium stearate.

Description of the appearance of Condiuren and package contents
Tablets packed in aluminum blisters containing 14 tablets and 28 tablets. Not all pack sizes may be commercially available.

Marketing Authorization 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 de’ Stampi
20089 Rozzano (Milan)