Lisinopril and hydrochlorothiazide Doc Generici

Package leaflet: Information for the user

LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici 20 + 12.5 mg tablets

Generic Medicine
Please read all of 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 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:

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

1. What LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics is and what it is used for

LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics is a combination of lisinopril and
hydrochlorothiazide.
Lisinopril is a medicine that lowers blood pressure (antihypertensive). It belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. It works by relaxing blood vessels, making it easier for blood to flow.
Hydrochlorothiazide is a diuretic belonging to the thiazide class. It causes the kidneys to produce more urine, thereby reducing blood volume.
LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics is used for:

• treating high blood pressure (essential hypertension).

LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics should be used in patients whose blood pressure is not adequately controlled by lisinopril alone.

2. What you need to know before taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC

Generics
Do not take LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics

• if you are allergic to lisinopril dihydrate, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to ACE inhibitors or sulfonamide medicines.
• if you have ever had sudden swelling of the hands, feet, ankles, face, lips, tongue, or throat, especially after treatment with an ACE inhibitor. You may also have had difficulty swallowing or breathing.
• if you have hereditary angioedema (a condition that makes you more prone to the swelling described above).
• if you are more than three months pregnant. (It is best to avoid LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics even in the early stages of pregnancy – see section Pregnancy.)
• if you have severe kidney problems.
• if you have stopped passing urine.
• if you have severe liver problems.
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
• 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, such as in the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics.
Inform your doctor if you have or have had any of the following medical conditions:

• low blood pressure due to loss of salts and/or fluids, for example because you are taking a medicine that increases urine production, are on dialysis, are on a low-salt diet, or have had vomiting or diarrhoea
• narrowing (stenosis) of the aorta (a heart artery) or of the renal artery
• thickening of the heart muscle (known as hypertrophic cardiomyopathy)
• kidney problems, are on dialysis, or have had a kidney transplant
• high cholesterol levels in the blood and are receiving a treatment called “LDL apheresis”
• liver problems
• are about to undergo surgery (including dental surgery); inform your doctor or dentist that you are taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics. This is because you may experience low blood pressure (hypotension) if certain local or general anaesthetics are administered while you are taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics
• if you have diabetes
• if you are at risk of increased potassium levels in the blood
• if you are undergoing or about to undergo treatment to reduce allergic reactions, such as insect stings (desensitisation treatment). Taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics during this treatment may cause you to have a severe allergic reaction
• if you have blood vessel disorders (vascular collagenosis)
• if you are of Black origin, as LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics may be less effective. You may also develop the side effect “angioedema” (a serious allergic reaction with swelling of the hands, feet, ankles, face, lips, tongue, or throat) more rapidly
• If you are taking any of the following medicines, the risk of angioedema may be increased.
• Racecadotril, a medicine used to treat diarrhoea.
• Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.
• If you have ever had a disease called systemic lupus erythematosus (SLE)
• If you have vision problems or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion), increased pressure inside the eye (glaucoma), or a significant reduction in vision (acute myopia), and may occur from a few hours to weeks after taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics. If left untreated, these conditions may lead to permanent vision loss. If you previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this disorder. If any of these symptoms occur, stop taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics and contact your doctor immediately, as medical treatment may be necessary.
• 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.
• 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 LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics.
• If you have previously had respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics, 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 section “Do not take LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics”.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant).
LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics is not recommended in early
pregnancy, and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken during this period (see section Pregnancy).
While taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics
If you develop any of the following symptoms, inform your doctor immediately:

• dizziness after the first dose. Some people react to their first dose or when the dose is increased with dizziness, weakness, fainting, nausea.
• symptoms such as dry mouth, thirst, weakness, lethargy, muscle pain or cramps, rapid heartbeat, dizziness, nausea, vomiting, and reduced urine production may indicate a disturbance in fluid or mineral balance.
• sudden swelling of the lips and face, neck, possibly also hands and feet, difficulty swallowing, hives, and difficulty breathing, or shortness of breath or hoarseness. This condition is called angioedema. This can occur at any time during treatment. ACE inhibitors cause a higher rate of angioedema in Black patients compared to patients of other races.
• high fever, sore throat, or mouth ulcers (these may be symptoms of infection due to reduced white blood cell count).
• yellowing of the skin and whites of the eyes (jaundice), which may be symptoms of liver disease.

In these cases, stop taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics and contact your doctor immediately. Your doctor will take appropriate measures.
At the beginning of treatment and/or during dose adjustment, you may need more frequent medical check-ups. Do not skip these visits even if you feel well. Your doctor will determine the frequency of follow-up tests.
If your blood pressure drops too low, you should lie down. If this persists, medical support may be needed. Inform your doctor if your blood pressure drops too low or frequently.
Anti-doping tests
The hydrochlorothiazide contained in this medicine may produce a positive result in anti-doping tests.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics must not be given to children, as the safety and efficacy of lisinopril/hydrochlorothiazide have not been established in this age group.
Other medicines and LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes over-the-counter medicines, herbal remedies, macrobiotic foods, or supplements.
Do not take LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics with sacubitril/valsartan (a medicine for treating heart failure) due to an increased risk of angioedema (rapid swelling under the skin, such as in the throat). See section “Do not take LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics”.
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 and HYDROCHLOROTHIAZIDE DOC Generics” and “Warnings and precautions”).
Inform your doctor if you are taking:
Lithium (a medicine for certain types of depression)
Increased risk of lithium poisoning. Concomitant use of LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics and lithium is not recommended. If this combination is necessary, your doctor must monitor lithium levels in your blood regularly.
Medicines that increase urine production with reduced potassium excretion (potassium-sparing diuretics, e.g. spironolactone, triamterene, amiloride), potassium supplements, potassium-containing salt substitutes, and other medicines associated with increased serum potassium (e.g. heparin and cotrimoxazole, also known as trimethoprim/sulfamethoxazole)
Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (such as trimetoprim 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 clot formation)
Medicines associated with “torsades de pointes”, a dangerous type of heart rhythm disorder
The risk of torsades de pointes is increased when potassium levels are low.
Medicines for depression and other psychiatric disorders (tricyclic antidepressants, antipsychotics), narcotics, anaesthetics
Additional reduction in blood pressure. Increased blood pressure lowering effect.
Medicines for pain and inflammation (non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid)
Concomitant use may reduce the blood pressure-lowering effect and may cause worsening of kidney function. Acute kidney failure may rarely occur, particularly in patients with impaired kidney function.
Gold (e.g. sodium aurothiomalate, which may be administered by injection)
Symptoms of vasodilation including flushing, nausea, dizziness, and hypotension, which may be severe.
Sympathomimetics (agents with a stimulating effect, e.g. increasing blood pressure)
Weakening of the blood pressure-lowering effect.
Medicines that lower blood pressure, vasodilators
Increased blood pressure lowering effect.
Medicines that lower blood sugar and insulin
Further reduction in blood glucose with risk of hypoglycaemia.
Amphotericin B (active ingredient for fungal infections), carbenoxolone (active ingredient for gastrointestinal ulcers), medicines containing cortisone (corticosteroids), corticotropin (a hormone acting on the adrenal glands), or certain laxatives
Disturbances in mineral balance, e.g. decreased potassium levels.
Calcium salts
Elevated serum calcium levels in the blood.
Cardiac glycosides (e.g. digoxin, active ingredient to increase cardiac output)
Increased action and side effects of cardiac glycosides.
Colestyramine and colestipol (active ingredients to lower blood lipid levels)
Weakened blood pressure-lowering effect. Delayed and reduced absorption of hydrochlorothiazide.
Muscle relaxants, e.g. tubocurarine chloride (active ingredient to relax muscles)
Increased and prolonged muscle-relaxing effect.
Trimethoprim (an antibiotic)
Increased risk of hyperkalaemia (high potassium levels in the blood).
Sotalol (used to treat irregular heartbeat and high blood pressure)
Increased risk of sotalol-induced arrhythmias (irregular heartbeat).
Allopurinol (active ingredient for treating gout)
Increases the risk of acute kidney failure and may increase the risk of low white blood cell count (leucopenia).
Cyclosporine (immunosuppressant used in organ transplants)
Increases the risk of acute kidney failure and raises blood potassium concentration.
mTOR inhibitors (such as sirolimus, everolimus, temsirolimus for organ transplant rejection), racecadotril (for diarrhoea), and vildagliptin (for diabetes).
Increased risk of angioedema. See section “Warnings and precautions”.
Cytoxotics (for treating cancer), immunosuppressants (to prevent rejection of a transplanted organ), procainamide (active ingredient for treating irregular heartbeat)
May increase the risk of reduced white blood cell count (leucopenia).
Other medicines that increase urine production (thiazides or loop diuretics)
Increased blood pressure lowering effect.
Lovastatin (active ingredient to lower cholesterol)
Increases blood potassium concentration.
Haemodialysis
Do not take LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics if you are undergoing haemodialysis. There is an increased risk of allergic reactions associated with certain types of dialysis membranes (see section “Warnings and precautions”).
LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics with food and drink
LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics.
LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics is not recommended during pregnancy, and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics is not recommended for women who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.
Driving and using machines
Like other medicines for lowering blood pressure, LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics may affect your ability to drive and use machinery. This is more likely at the beginning of treatment, during dose adjustments, or when combined with alcohol. These effects depend on your individual sensitivity. If this applies to you, do not drive or operate machinery.
Excipients
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Take the tablet with a full glass of water at the same time each day.
The recommended dose is:
Adults
1 tablet once daily.
Elderly population
Dose adjustment is not required.
Use in children and adolescents
LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics is not recommended for use in children and adolescents.
Reduced renal function
Dose adjustment may be necessary. Follow your doctor's instructions.
If you take more LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics than you should
Inform your doctor, emergency services, or pharmacist if you have taken more LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics than indicated in this leaflet or more than prescribed by your doctor.
Overdose may cause excessively low blood pressure, dehydration, electrolyte disturbances, and renal failure.
If you forget to take LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics
Do not take a double dose to make up for the missed dose. Follow your doctor's instructions.
If you stop taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics
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 everyone gets them.

Possible side effects with lisinopril

Severe allergic reactions (rare, may affect up to 1 in 1,000 people)
If you have a severe allergic reaction, stop taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici and consult a doctor immediately.
Signs may include sudden onset of:

• Swelling of the face, lips, tongue or throat. This makes swallowing difficult.
• Severe or sudden swelling of the hands, feet or ankles.
• Difficulty breathing.
• Severe itching of the skin (with bumps).

Severe liver problems (very rare, may affect up to 1 in 10,000 people)
Signs may include:

• Yellowing of the skin or eyes, dark-coloured urine or loss of appetite. If this happens to you, consult a doctor immediately.

Other possible side effects

Common (may affect up to 1 in 10 people)

• Headache.
• Dizziness or feeling lightheaded, especially when standing up quickly.
• Fainting.
• Diarrhoea.
• Feeling unwell (vomiting).
• Cough.
• Kidney problems (shown in a blood test).

Uncommon (may affect up to 1 in 100 people)

• Mood changes, including depression.
• Tingling sensation felt as “pins and needles”.
• Feeling of spinning (dizziness).
• Changes in taste.
• Difficulty sleeping.
• Heart attack or stroke.
• Irregular heartbeat.
• Change in the colour of fingers and toes.
• Runny nose.
• Feeling unwell (nausea).
• Stomach ache and indigestion.
• Changes in blood tests that check how the liver is working.
• Rash.
• Itching.
• Inability to get an erection (impotence).
• Feeling weak.
• Feeling tired.
• Increased levels of certain substances in the blood (urea, creatinine or potassium).

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

• Changes in certain blood cells or other blood components. Signs may include feeling tired and pale skin.
• Feeling confused.
• Dry mouth.
• Skin rash with itchy, red, swollen lumps (hives).
• Hair loss (alopecia).
• Psoriasis (a skin condition).
• Blood infection.
• Kidney failure.
• Breast enlargement in men.
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH).
• Low levels of sodium in the blood, which may cause weakness, tiredness, headache, nausea, feeling unwell (vomiting) and cramps.

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

• Problems with bone marrow or reduced number of blood cells and/or platelets. You may notice tiredness, infection (which may be severe), fever, shortness of breath or easier bruising or bleeding.
• Swollen glands (lymph nodes).
• Increased immune response (autoimmune disease).
• Low blood sugar levels (hypoglycaemia). Signs may include feeling hungry or weak, sweating and rapid heartbeat.
• Sudden wheezing and shortness of breath (bronchospasm).
• Lung inflammation (which may make you feel breathless).
• Sinusitis (a feeling of pain and swelling behind the cheeks and eyes).
• Eosinophilic pneumonia. Signs include a combination of the following side effects:
• Sinusitis
• Feeling like you have the flu
• Increasing breathlessness
• Pain in the stomach or intestinal area
• Rash
• A “tingling” or numbness sensation in the arms or legs.
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Swelling of the lining of the intestine. This may cause sudden stomach pain, diarrhoea or feeling unwell (vomiting).
• Sweating.
• Severe skin disorders or skin rash. Symptoms include redness, blisters and peeling of the skin, which may develop rapidly, and may include blisters in the mouth and nose.
• Reduced or no urine production.
• Hepatitis – hepatocellular or cholestatic, jaundice, liver failure.

Frequency not known (frequency cannot be estimated from the available data)

• Depression.
• Hot flushes.

Possible side effects with hydrochlorothiazide

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

• Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Frequency not known (frequency cannot be estimated from the available data)

• Inflammation of a salivary gland.
• Reduction in the number of blood cells and/or platelets. You may notice tiredness, infection (which may be severe), fever, shortness of breath or easier bruising or bleeding.
• Loss of appetite.
• Increased amount of sugar (glucose) in the blood.
• Sugar in the urine.
• Increased amount of uric acid in the blood.
• Altered levels of certain substances in the blood (for example, low levels of sodium and potassium). You may notice muscle weakness, thirst, “pins and needles” sensation in the skin, muscle cramps or feeling unwell.
• Increased or high levels of fats in the blood (including cholesterol).
• Gout.
• Feeling restless.
• Depression.
• Difficulty sleeping.
• Tingling sensation, felt as "pins and needles".
• Feeling lightheaded.
• Brief vision problems.
• Eye and vision problems such as “yellow vision” and blurred vision, sudden-onset short-sightedness (acute myopia), reduced 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).
• Feeling of spinning (dizziness).
• Feeling faint (especially when standing).
• Damage to blood vessels causing reddish or purplish spots on the skin.
• Breathing difficulties. You may feel breathless if the lungs become inflamed or contain fluid.
• Stomach irritation.
• Diarrhoea.
• Constipation.
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Yellowing of the skin or whites of the eyes (jaundice).
• Skin problems, including rash due to sensitivity to sunlight, rash, severe rash developing rapidly with blisters or peeling of the skin and, possibly, blisters in the mouth, worsening of existing lupus-like reactions or appearance of unusual skin reactions.
• Allergic reactions.
• Muscle cramps and muscle weakness.
• Kidney problems, which may be serious (shown in blood tests).
• Fever.
• Weakness.
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects

If you get any side effects, including ones 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 LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton 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

What LISINOPRIL and IDROCLOROTIAZIDE DOC Generici contains

• The active substances are lisinopril as lisinopril dihydrate and hydrochlorothiazide. Each tablet contains lisinopril dihydrate equivalent to 20 mg of lisinopril and 12.5 mg of hydrochlorothiazide.
• The other components are: mannitol, calcium hydrogen phosphate dihydrate, pregelatinized corn starch, sodium croscarmellose, magnesium stearate.

Description of the appearance of LISINOPRIL and IDROCLOROTIAZIDE DOC Generici and package contents
White, round tablets, engraved with "LH" on one side.
Pack sizes:
PVC/PVDC-Al blisters: 14 and 28 tablets.
PP container: 30 and 100 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturer
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: LISINOPRIL and IDROCLOROTIAZIDE DOC Generici