Lisinopril hydrochlorothiazide Sandoz: detailed information

Package leaflet: Information for the patient

Lisinopril Hydrochlorothiazide Sandoz 20 mg/12.5 mg tablets

Lisinopril and hydrochlorothiazide
Generic medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lisinopril Hydrochlorothiazide Sandoz is and what it is used for
What you need to know before taking Lisinopril Hydrochlorothiazide Sandoz
How to take Lisinopril Hydrochlorothiazide Sandoz
Possible side effects
How to store Lisinopril Hydrochlorothiazide Sandoz
Contents of the pack and other information

1. What Lisinopril Hydrochlorothiazide Sandoz is and what it is used for

Lisinopril, which belongs to a group of medicines called "angiotensin-converting enzyme inhibitors" (ACE inhibitors), lowers blood pressure by dilating blood vessels.
Hydrochlorothiazide, which belongs to a group of medicines called diuretics, reduces blood pressure by increasing urine production.
Lisinopril Hydrochlorothiazide Sandoz contains a combination of lisinopril and hydrochlorothiazide and is used to treat high blood pressure when treatment with lisinopril alone has proven insufficient.
Your doctor may also prescribe Lisinopril Hydrochlorothiazide Sandoz instead of separate, identical doses of lisinopril and hydrochlorothiazide. Fixed-dose combination therapy is not suitable for initiating treatment.

2. What you need to know before taking Lisinopril Hydrochlorothiazide Sandoz

DO NOT take Lisinopril Hydrochlorothiazide Sandoz

if you are allergic to lisinopril, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6)
if you are allergic to other ACE inhibitors, for example ramipril, or to medicines derived from sulfonamides (mainly antibiotics such as sulfamethoxazole)
if you have previously experienced swelling of the extremities, face, lips, throat, mouth, or tongue (angioedema) when taking other medicines belonging to a class of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors), such as ramipril
if you have previously experienced swelling of the extremities, face, lips, throat, mouth, or tongue (angioedema) under any other circumstances
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 under the skin, for example in the throat)
if any of your family members have previously experienced swelling of the extremities, face, lips, throat, mouth, or tongue (angioedema)
if you suffer from severe kidney problems
if you suffer from severe liver problems
if you have inability to produce urine (anuria)
if you are more than 3 months pregnant (it is best to avoid Lisinopril Hydrochlorothiazide Sandoz in early pregnancy – see section “Pregnancy and breastfeeding”)
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Tell your doctor or pharmacist before taking Lisinopril Hydrochlorothiazide Sandoz:

if you suffer from narrowing of the arteries (atherosclerosis), cerebrovascular disorders such as stroke or transient ischaemic attack (TIA, so-called “mini-stroke”)
if you suffer from heart failure
if you have low blood pressure, are on a low-salt diet, or are taking diuretics
if you have abnormal levels of water and minerals in your body (water/electrolyte imbalance)
if you suffer from a heart muscle disease (hypertrophic cardiomyopathy), narrowing of the aorta, the main artery carrying blood from the heart (aortic stenosis), or another form of heart disorder called outflow obstruction
if you are due to undergo LDL apheresis (removal of cholesterol from the blood using a machine)
if you are due to undergo desensitisation therapy for certain insect venoms, such as bee or wasp stings
if you suffer from diabetes
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. Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section “Do not take Lisinopril Hydrochlorothiazide Sandoz”.
If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin, for example in the throat) may be increased:
medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus)
racecadotril, a medicine used to treat diarrhoea
vildagliptin, a medicine used to treat diabetes
if you suffer from gout, have high levels of uric acid in your blood, or are being treated with allopurinol
if you are due to receive an anaesthetic
if you have recently experienced severe and prolonged vomiting and/or severe diarrhoea
if you are due to undergo tests to monitor parathyroid function
if you suffer from or have suffered from liver or kidney problems, narrowing of the arteries to the kidneys (renal artery stenosis), have only one functioning kidney, or are due to undergo haemodialysis
if you suffer from collagen vascular diseases such as systemic lupus erythematosus (SLE) or scleroderma, which may be associated with skin rashes, joint pain, and fever
if you have previously had skin cancer or 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 cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Lisinopril Hydrochlorothiazide Sandoz
if you have allergies or asthma
if you are taking lithium, used to treat certain psychiatric disorders
if you think you are (or might be) pregnant. Lisinopril Hydrochlorothiazide Sandoz is not recommended in early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the unborn child if taken during this period (see section “Pregnancy”)
if you are being treated with other diuretics. The other treatment should be discontinued 2–3 days before starting Lisinopril Hydrochlorothiazide Sandoz

Lisinopril Hydrochlorothiazide Sandoz is generally not recommended in the following cases; therefore, consult your doctor before starting this medicine:

if you have recently undergone a kidney transplant
if you have high levels of potassium in your blood

See also section “Other medicines and Lisinopril Hydrochlorothiazide Sandoz” below.
If you are an athlete about to undergo anti-doping testing, consult your doctor, as Lisinopril Hydrochlorothiazide Sandoz contains an active substance that may lead to positive results in anti-doping tests.
Elderly or malnourished patients should exercise particular caution when using Lisinopril Hydrochlorothiazide Sandoz.
Lisinopril Hydrochlorothiazide Sandoz may be less effective in patients of Black origin.
Children
The use of this medicine is not recommended in children.
While being treated with Lisinopril Hydrochlorothiazide Sandoz
If you develop any of the following symptoms, inform medical personnel immediately:

Dizziness after the first dose. Some people experience dizziness, weakness, fainting, or nausea after the first dose or after a dose increase
Sudden swelling of the lips, face, and neck, possibly also hands and feet, or shortness of breath and hoarseness. This condition is called angioedema and can occur at any time during treatment. ACE inhibitors cause a higher incidence of angioedema in Black patients compared to non-Black patients
High temperature, sore throat, or mouth ulcers (these may be symptoms of an infection caused by a reduction in white blood cells)
Yellowing of the skin and whites of the eyes (jaundice), which may be a sign of liver disease
Persistent dry cough. Cough has been reported with the use of ACE inhibitors, although it may also be a symptom of other upper airway diseases
Myopathy or glaucoma

This medicine contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.
Other medicines and Lisinopril Hydrochlorothiazide Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important for:

potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting)
other medicines used to treat high blood pressure. Your doctor may need to adjust your dose and/or take other precautions: If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take Lisinopril Hydrochlorothiazide Sandoz” and “Warnings and precautions”)
anaesthetics and medicines used for mental disorders or depression, medicines for treating psychosis, tricyclic antidepressants, or sedatives
lithium, a medicine for depression
painkillers and anti-inflammatory medicines, such as acetylsalicylic acid (>3000 mg/day) or indomethacin
sodium aurothiomalate (gold), an injectable medicine for rheumatoid arthritis
sympathomimetic medicines, such as ephedrine, noradrenaline, or adrenaline, used to treat low blood pressure, shock, heart failure, asthma, or allergies
hypoglycaemic medicines, such as insulin or oral antidiabetics
cholestyramine and colestipol resins, active substances used to lower blood lipid levels
corticosteroids, anti-inflammatory substances similar to hormones
ACTH, used to check proper functioning of the adrenal glands
muscle relaxants (such as tubocurarine chloride), medicines used to relax muscles during surgery
allopurinol, a medicine used to treat gout
medicines used to treat cancer, such as cyclophosphamide or methotrexate
medicines that suppress the immune system, medicines used to prevent rejection after organ or bone marrow transplantation
cardiac glycosides (such as digoxin), medicines used to strengthen the heart
medicines that, as a side effect, cause abnormalities in cardiac conduction, such as those used for heart rhythm disorders, some medicines for psychosis, and other medicines, such as those used to treat bacterial infections
calcium salts, used to increase calcium levels in the blood
amphotericin B, a medicine used to treat fungal infections
laxatives, medicines used to stimulate bowel movements
carbenoxolone, a medicine used to treat gastrointestinal disorders
medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”
lovastatin, a medicine used to treat high cholesterol
sotalol (a beta-blocker): increases the risk of arrhythmia

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you think you are (or might be) pregnant, inform your doctor. Your doctor will usually advise you to stop taking Lisinopril Hydrochlorothiazide Sandoz before becoming pregnant or as soon as pregnancy is diagnosed, and to take an alternative medicine instead. Lisinopril Hydrochlorothiazide Sandoz is not recommended during pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the unborn child if used after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Lisinopril Hydrochlorothiazide Sandoz is not recommended for breastfeeding women, and if you wish to breastfeed, your doctor may choose an alternative treatment, especially if the baby is a newborn or was born prematurely.
Driving and using machines
Patients taking Lisinopril Hydrochlorothiazide Sandoz have reported dizziness and fatigue. If you experience any of these effects, do not drive or operate machinery (see section 4, “Possible side effects”).

3. How to take Lisinopril Hydrochlorothiazide Sandoz

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is one tablet once daily.
The maximum daily dose is 40 mg of lisinopril and 25 mg of hydrochlorothiazide.
Use in children
The safety and efficacy in children and adolescents have not been established.
Elderly
No specific dose adjustment is necessary.
Kidney problems
Do not take this medicine if your kidney function is severely impaired. If you suffer from a
kidney disease, your doctor must prescribe the lowest possible dose and monitor your kidney function.
Previous treatment with diuretics
If switching from treatment with diuretics to Lisinopril Hydrochlorothiazide Sandoz, you must stop taking
the diuretics 2–3 days before starting to take this medicine.
How to take the tablets
Take the tablet or half tablet with a full glass of water. Try to take the
medicine at the same time every day.
Tablet splitting
Place the tablet on a hard, flat surface with the score line facing upwards. Press down with one finger at the centre of the tablet and it will break into two parts.
If you take more Lisinopril Hydrochlorothiazide Sandoz than you should
If you (or someone else) have taken an excessive number of tablets at once, or if you suspect that a
child has ingested any number of tablets, contact a doctor immediately.
An overdose is likely to cause hypotension, circulatory shock, electrolyte disturbances, renal failure,
hyperventilation (rapid breathing, nausea and vomiting), excessively fast or slow heartbeat, palpitations (sensation of abnormally rapid or irregular heartbeat), dizziness, anxiety and
cough. Take this leaflet, any remaining tablets and the container with you to the hospital or doctor, so that medical staff can identify which tablets have been taken.
If you forget to take Lisinopril Hydrochlorothiazide Sandoz
Do not take a double dose to make up for a forgotten tablet; take the next dose at the usual time.
If you stop taking Lisinopril Hydrochlorothiazide Sandoz
Treatment of high blood pressure is long-term therapy, and stopping treatment should be discussed with your doctor. Interrupting or stopping therapy may cause an increase in
blood pressure.
If you have any questions 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.
If you experience any of the effects listed below, stop taking this medicine immediately and contact your doctor or go to the nearest hospital emergency department:

a severe allergic reaction called angioedema (rash, itching, swelling of the extremities, face, lips, mouth or throat, which may cause difficulty swallowing or breathing). This is a serious and rare side effect (may affect up to 1 in 1,000 people). You may need urgent medical treatment or hospitalisation.
jaundice (yellowing of the skin and whites of the eyes). This is a potentially serious but very rare side effect (may affect up to 1 in 10,000 people), indicating liver inflammation. You may need urgent medical treatment or hospitalisation.
Not passing urine (low urine output), which may also occur with high temperature (fever), nausea, tiredness, flank pain, swelling of the legs, ankles, feet, face and hands, or blood in the urine. These are due to kidney problems. This is a serious and rare side effect (may affect up to 1 in 1,000 people) due to severe kidney problems (sudden kidney failure). Lisinopril Hydrochlorothiazide Sandoz commonly causes (may affect up to 1 in 10 people) low blood pressure, which may be associated with dizziness and weakness. In some patients, this may occur after the first dose or when the dose is increased. If you experience these symptoms, contact your doctor immediately.

Lisinopril Hydrochlorothiazide Sandoz may reduce the number of white blood cells, which could decrease resistance to infections. If you develop an infection with symptoms such as fever and severe worsening of general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems, consult your doctor immediately. Your doctor will prescribe a blood test to check for possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor that you are taking this medicine.
With the use of Lisinopril Hydrochlorothiazide Sandoz and other ACE inhibitors, a dry cough has been commonly reported (may affect up to 1 in 10 people), which may persist for a long time, but may also be a symptom of another upper respiratory tract disease. If you develop this symptom, consult your doctor.

The following side effects have also been reported:
Common (may affect up to 1 in 10 people)

dizziness, headache, sudden loss of consciousness
low blood pressure associated with changes in posture (such as lightheadedness or weakness when standing up from lying down)
cough (see beginning of this section)
diarrhoea, vomiting
kidney problems.

Uncommon (may affect up to 1 in 100 people)

mood changes
tingling or numbness, dizziness, altered taste, difficulty sleeping
heart attack or stroke (“mini-stroke”) (mainly in patients suffering from low blood pressure)
palpitations (sensation of a fast, strong or irregular heartbeat)
excessively fast heartbeat (tachycardia)
Raynaud's syndrome, a blood vessel disorder that may cause tingling in fingers and toes, followed by whitening, bluish discoloration and then reddening
inflammation of the nasal lining causing runny nose (rhinitis)
nausea, abdominal pain and indigestion
increased levels of liver enzymes and waste products
skin rashes and/or itching
impotence
tiredness, general weakness
increased levels of urea in the blood
high levels of potassium in the blood, which may cause an abnormal heart rhythm; increased levels of creatinine in the blood.

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

decrease in haemoglobin (red pigment in blood) and number of red blood cells (haematocrit)
mental confusion
dry mouth
hypersensitivity/angioedema (see beginning of this section), itchy rash, hair loss, raised red/silver patches on the skin
kidney problems
breast enlargement in men
low levels of sodium in the blood, which may cause tiredness and confusion, muscle cramps, seizures or coma, and even dehydration and low blood pressure, resulting in dizziness upon standing.
Syndrome of inappropriate antidiuretic hormone secretion (SIADH). Symptoms include weight gain, nausea, vomiting, muscle cramps, confusion and seizures.

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

reduction in the number of white blood cells, making infections more likely, reduction in the number of other blood cells, poor bone marrow production, lymph node disorders, autoimmune disease, where the body attacks itself
reduction in the number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath (anaemia)
hypoglycaemia (low blood sugar levels) (see “Warnings and precautions” in section 2)
difficulty breathing, shortness of breath
inflammation of the sinuses
lung problems, including pneumonia
inflammation of the pancreas causing severe abdominal and back pain (pancreatitis)
intestinal swelling
liver problems*
excessive sweating (diaphoresis), severe skin disorders including Stevens-Johnson syndrome and clusters of mature or atypical lymphocytes in the dermis (cutaneous pseudolymphoma)**
absence of urge to urinate or less frequent urination (low urine output)

* Very rarely, in some patients, unwanted development of hepatitis has progressed to liver failure. Patients treated with the combination lisinopril/hydrochlorothiazide who develop jaundice or marked increases in liver enzymes should discontinue the lisinopril/hydrochlorothiazide combination and receive appropriate follow-up.
** A complex of symptoms has been reported which may include one or more of the following: fever, inflammation of a blood vessel (vasculitis), muscle pain (myalgia), joint pain (arthralgia) and joint inflammation (arthritis), increased levels of antibodies (ANA), increased erythrocyte sedimentation rate, rash and increased white blood cell count (eosinophilia and leucocytosis), skin rash, photosensitivity or other skin reactions.

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

skin and lip cancer (non-melanoma skin cancer)
inflammation of a salivary gland
increased levels of sugar, fat (including cholesterol) or uric acid in the blood, painful and swollen joints (gout), sugar in the urine; low levels of potassium in the blood, which may cause muscle weakness, cramps or heart rhythm abnormalities; decreased levels of magnesium and chloride in the blood
stomach irritation
constipation
loss of appetite
restlessness
shortness of breath due to fluid in the lungs
vision disturbances
inflammatory disease of blood vessels (necrotizing vasculitis)
skin sensitivity to light, skin disorders with scaly red patches on the nose and cheeks (lupus erythematosus) – this condition may worsen in patients who already suffer from it, severe allergic reactions
muscle cramps, muscle weakness
inflammation of the kidneys (interstitial nephritis)
fever
depression
flushing

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 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 Lisinopril Hydrochlorothiazide Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and outer carton after the word
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Pack contents and other information

What Lisinopril Hydrochlorothiazide Sandoz contains
The active substances are lisinopril and hydrochlorothiazide.
Each tablet contains 20 mg of lisinopril (as dihydrate) and 12.5 mg of hydrochlorothiazide.
The other components are: calcium hydrogen phosphate dihydrate, sodium croscarmellose, mannitol, maize starch, magnesium stearate and red iron oxide (E 172).

Description of the appearance of Lisinopril Hydrochlorothiazide Sandoz and pack contents
The tablets are pink, round, biconvex and have a break line on one side.
The tablets are packaged in PVC/aluminum blisters contained in cardboard boxes.
Lisinopril Hydrochlorothiazide Sandoz is available in packs of 14, 28, 30, 50, 56, 98, 100 and 400 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia

This medicinal product is authorised in the European Economic Area countries under the following names:
BE: Co-Lisinopril Sandoz 10 mg/12.5 mg tabletten
Co-Lisinopril Sandoz 20 mg/12.5 mg tabletten
IE: Lispril-Hydrochlorothiazide 10 mg/12.5 mg tablets
Lispril-Hydrochlorothiazide 20 mg/12.5 mg tablets
IT: Lisinopril Idroclorotiazide Sandoz
PT: Lisinopril + Hidroclorotiazida Sandoz 20 mg + 12.5 mg comprimidos
ES: Lisinoprilo Hidroclorotiazida Bexal 20/12.5 mg comprimidos EFG