LISINOPRIL 20 mg /12.5 Mg Tabletka Powlekana

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1. LISINOPRIL e IDROCLOROTIAZIDE DOC Generici 20 + 12,5 mg compresse
   1. What is LISINOPRIL and IDROCLOROTIAZIDE DOC Generici and what is it used for
   2. What you need to know before taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC
   3. How to take LISINOPRIL and IDROCLOROTIAZIDE DOC Generici
   4. Possible side effects
   5. How to store LISINOPRIL and IDROCLOROTIAZIDE DOC Generici
   6. Contents of the pack and other information

LISINOPRIL e IDROCLOROTIAZIDE DOC Generici 20 + 12,5 mg compresse

Equivalent Medicine

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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is LISINOPRIL and IDROCLOROTIAZIDE DOC Generici and what is it used for

LISINOPRIL and IDROCLOROTIAZIDE DOC Generici is a combination of lisinopril and
hydrochlorothiazide.
Lisinopril is a medication 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 that belongs to the thiazide class. It causes the kidneys to produce more urine and
therefore reduces blood volume.
LISINOPRIL and IDROCLOROTIAZIDE DOC Generici is used for:

• treating high blood pressure (essential hypertension).

LISINOPRIL and IDROCLOROTIAZIDE DOC Generici 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 drugs.
• if you have ever experienced sudden swelling of the hands, feet, ankles, face, lips, tongue or throat, especially after treatment with an ACE inhibitor. It may also have been difficult to swallow or breathe.
• if you have hereditary angioedema (a condition that makes you more prone to the swelling described above).
• if you are pregnant for more than three months. (It is best to avoid LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics even in the early stages of pregnancy - see the Pregnancy section).
• if you have severe kidney problems.
• if you have stopped passing urine.
• if you have severe liver problems.
• 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.
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC
Generics.
Tell your doctor if you suffer from or have suffered from any particular medical condition among the following:

• if you have low blood pressure because you have experienced a loss of salts and/or fluids, for example because you are taking a medicine that increases urine production or if you are on dialysis or if you are on a low-salt diet or due to vomiting or diarrhea
• if you have a narrowing (stenosis) of the aorta (an artery of the heart) or the renal artery
• if you have an increase in the thickness of the heart muscle (known as hypertrophic cardiomyopathy)
• if you have kidney problems or are on dialysis or have had a kidney transplant
• if you have high levels of cholesterol in your blood and are receiving a treatment called “LDL apheresis”
• if you have liver problems
• if you are about to undergo surgery (including dental surgery) tell your doctor or dentist that you are taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics. This is because you may have low blood pressure (hypotension) if you are given certain local and general anesthetics while taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics
• if you have diabetes
• if you are at risk of an increase in potassium levels in your blood
• if you are undergoing or are about to undergo treatment to reduce the effects of an allergy, such as insect stings (desensitizing treatment). If you take LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics while receiving this treatment, it may cause you a severe allergic reaction
• if you have problems with blood vessels (vascular collagenopathy)
• if you are of black origin, as LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics may be less effective. You may also experience the side effect “angioedema” (a severe allergic reaction with swelling of the hands, feet, ankles, face, lips, tongue or throat) more quickly
• If you are taking any of the following medicines, the risk of angioedema may be increased.
• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent 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 blurred vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure inside the eye (glaucoma) or a significant reduction in vision (acute myopia) and can occur within a period ranging from a few hours to weeks after taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics. If left untreated, these conditions can lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may be at a higher risk of developing this disorder. If any of these symptoms occur, stop taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics and inform your doctor immediately as medical treatment may be considered.
• If you are taking any of the following medicines used to treat high blood pressure:
• 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.
• 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, can increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics.
• If you have had breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics, consult a doctor immediately.

The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also what is reported under “Do not take LISINOPRIL and HYDROCHLOROTHIAZIDE DOC
Generics”.
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant).
LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics is not recommended in early
pregnancy, and should not be taken if you are pregnant for more than three months, as it
can cause serious harm to the baby if taken during this period (see the Pregnancy section).

While taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics
If you develop any of the following symptoms, tell your doctor immediately:

• if you feel dizzy 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 decreased urine production may be a sign of a disturbance of fluid or mineral balance.
• sudden swelling of the lips and face, neck, possibly also hands and feet, difficulty swallowing, hives and difficulty breathing, or wheezing 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 than in patients of other races.
• high fever, sore throat or mouth ulcers (these may be symptoms of infection caused by a decrease in the number of white blood cells).
• yellowing of the skin and whites of the eyes (jaundice) which may be symptoms of a liver disease.

In these cases, stop taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics and contact
your doctor immediately. The doctor will take appropriate measures.
At the beginning of treatment and/or during the dose adjustment period, you may need an
increased frequency of medical check-ups. Do not skip these visits if you feel better. The
doctor will determine the frequency of check-ups.
If your blood pressure drops too much, you should lie down. If this persists, medical
support may be necessary. Tell your doctor if your blood pressure drops too much or frequently.

Doping tests
The hydrochlorothiazide contained in this medicine can produce a positive result in doping tests.
For those who engage in sports: the use of the drug without therapeutic need constitutes doping and may
still result in a positive doping test.

Children and adolescents
LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics should 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines, herbal remedies, macrobiotic foods or supplements that you may have taken without a prescription.
Do not take LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics with sacubitril/valsartan (medicine for treating heart failure) due to an increased risk of angioedema (rapid swelling under the skin in areas such as the throat). See paragraph “Do not take LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics”.
Your 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 stated under “Do not take LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics” and “Warnings and precautions”).
Tell your doctor if you are taking:

Lithium (medicine for some types of depression)
Increased risk of lithium poisoning. Using LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics and lithium at the same time is not recommended. If this combination is nevertheless necessary, lithium levels in the blood must be monitored regularly by your doctor.

Medicines that increase urine production with reduced potassium excretion (potassium-sparing diuretics, e.g. spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium and other medicines associated with an increase in serum potassium (e.g. heparin and cotrimoxazole also known as trimethoprim/sulfamethoxazole)
Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that could increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, a medicine immunosuppressant used to prevent organ rejection; and heparin, a medicine used to thin the blood and prevent the formation of clots)

Medicines associated with “torsades de pointes”, a dangerous type of heart rhythm disturbance
The risk of torsades de pointes is increased when potassium levels are low.

Medicines for depression, and medicines for other mental illnesses (tricyclic antidepressants, antipsychotics), narcotics, anesthetics
Further reduction of blood pressure. Increased reduction of blood pressure.

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 a deterioration of renal function. Rarely, acute renal failure may occur, particularly in patients with impaired renal function.

Gold (e.g. sodium aurothiomalate, which can be administered as an injection)
Symptoms of vasodilation including flushing, nausea, dizziness and hypotension, which can be very severe.

Sympathomimetics (agents with a stimulating effect e.g. increasing blood pressure)
Weakening of the blood pressure lowering effect.

Medicines that lower blood pressure, medicines that dilate blood vessels
Increased reduction of blood pressure.

Medicines that lower blood sugar and insulin
Further decrease in blood glucose with the risk of hypoglycemia.

Amphotericin B (active ingredient against fungal infections), carbenoxolone (active ingredient for the treatment of gastrointestinal ulcers), medicines containing cortisone (corticosteroids), corticotropin (a hormone that acts on the adrenal glands) or some laxatives
Disturbances of mineral balance, e.g. decreased potassium values.

Calcium salts
Elevated blood serum calcium levels.

Cardiac glycosides (e.g. digoxin, active ingredient to increase cardiac output)
Increased action and undesirable effects of cardiac glycosides.

Cholestyramine and colestipol (active ingredients to decrease fat values in the blood)
Weakening of the 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 hyperkalemia (high levels of potassium in the blood).

Sotalol (for treating irregular heartbeat and high blood pressure)
Increased risk of sotalol-induced arrhythmias (irregular heartbeat).

Allopurinol (active ingredient to treat gout)
Increases the risk of acute renal failure and may cause an increased risk of a low number of white blood cells (leukopenia).

Cyclosporine (immunosuppressant used in organ transplants)
Increases the risk of acute renal failure and increases the concentration of potassium in the blood.

mTOR inhibitors (such as sirolimus, everolimus, temsirolimus for organ rejection), racecadotril (for diarrhea) and vildagliptin (for diabetes).
Increased risk of angioedema. See paragraph “Warnings and precautions”.

Cytostatic agents (for treating cancer), immunosuppressants (to prevent rejection of a transplanted organ), procainamide (active ingredient for treating irregular heartbeat)
May cause an increased risk of a decrease in the number of white blood cells (leukopenia).

Other medicines that increase urine production (thiazides or loop diuretics)
Increased reduction of blood pressure.

Lovastatin (active ingredient to decrease cholesterol)
Increases the concentration of potassium in the blood.

Hemodialysis
You should not take LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics if you are undergoing hemodialysis. There is an increased risk of allergic reactions associated with some types of dialysis membranes (see paragraph “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 are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). As a rule, your doctor will advise you to stop taking LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics before starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics.
LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics is not recommended during pregnancy, and should not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding.
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 newborn or premature.

Driving and using machines
As with other medicines for lowering blood pressure, LISINOPRIL and HYDROCHLOROTHIAZIDE DOC Generics may reduce your ability to drive vehicles and operate machinery. This is more likely to occur at the beginning of treatment, with dose adjustments or in association with alcohol. These effects depend on your sensitivity. If this affects you, do not drive or use machines.

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 IDROCLOROTIAZIDE DOC Generici

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult
your doctor or pharmacist.
Take the tablet with a full glass of water and at the same time each day.
The recommended dose is:

Adults
1 tablet once a day.

Elderly population
No dose adjustment is necessary.

Use in children and adolescents
LISINOPRIL and IDROCLOROTIAZIDE DOC Generici is not recommended for use in children and
adolescents.

Reduced renal function
A dose adjustment may be necessary. Follow your doctor's instructions.

If you take more LISINOPRIL and IDROCLOROTIAZIDE DOC Generici than you should
Inform your doctor, the emergency room, or your pharmacist if you have taken more LISINOPRIL and
IDROCLOROTIAZIDE DOC Generici than is written in this leaflet or more than your
doctor has prescribed.
An overdose can cause excessively low blood pressure, dehydration, electrolyte disturbances, and
renal failure.

If you forget to take LISINOPRIL and IDROCLOROTIAZIDE DOC Generici
Do not take a double dose to make up for a missed dose. Follow your doctor's instructions.

If you stop taking LISINOPRIL and IDROCLOROTIAZIDE DOC Generici
If you have any doubts 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.

Possible side effects with lisinopril
Serious allergic reactions(rare, may affect up to 1 in 1,000 people)
If you have a serious allergic reaction, stop taking LISINOPRIL and IDROCLOROTIAZIDE
DOC Generici and tell your doctor immediately.
The signs can include sudden onset of:

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

Serious liver problems(very rare, may affect up to 1 in 10,000)
The signs can include:

• Yellowing of the skin or eyes, dark urine, or loss of appetite. If this happens to you, see your doctor immediately.

Other possible side effects
Common(may affect up to 1 in 10 people)

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

Not common(may affect up to 1 in 100 people)

• Changes in mood, including depression.
• Pins and needles sensation.
• Feeling of spinning (vertigo).
• Changes in taste.
• Difficulty sleeping.
• Heart attack or stroke.
• Unusual heartbeat.
• Change in the colour of your fingers or toes.
• Runny nose.
• Feeling sick (nausea).
• Stomach pain and indigestion.
• Changes in blood tests that check how your liver is working.
• Skin 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 to some blood cells or other parts of the blood. The signs can include feeling tired and pale skin.
• Feeling confused.
• Dry mouth.
• Skin rash with dark red, raised, itchy bumps (urticaria).
• Hair loss (alopecia).
• Psoriasis (a skin problem).
• Blood infection.
• Kidney failure.
• Breast enlargement in men.
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH).
• Low levels of sodium in the blood, which can cause weakness, tiredness, headache, nausea, feeling sick (vomiting) and cramps. Very rare(may affect up to 1 in 10,000)
• Problems with the bone marrow or reduced number of blood cells and/or platelets. You may notice tiredness, infection (which can be severe), fever, feeling short of breath or easier bruising or bleeding.
• Swollen glands (lymph nodes).
• Increased immune response (autoimmune disease).
• Low blood sugar levels (hypoglycaemia). The signs can include feeling hungry or weak, sweating and a fast heartbeat.
• Sudden wheezing and shortness of breath (bronchospasm).
• Inflammation of the lungs (which can make you feel breathless).
• Sinusitis (a feeling of pain and swelling behind your cheeks and eyes).
• Eosinophilic pneumonia. The signs include a combination of the following side effects:
• Sinusitis
• Flu-like symptoms
• Feeling increasingly breathless
• Pain in the area of your stomach or intestines
• Skin rash
• A sensation of “pins and needles” or numbness in your arms or legs.
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Swelling of the lining of the intestine. This can cause sudden stomach pain, diarrhoea or feeling sick (vomiting).
• Sweating.
• Severe skin disorders or rash. The symptoms include redness, blisters and peeling of the skin, which can develop rapidly, and may include blisters in the mouth and nose.
• Reduced or absent urine production.
• Hepatitis – hepatocellular or cholestatic, jaundice, liver failure.

Frequency not known(the 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)

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

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

• Inflammation of a salivary gland.
• Reduced number of blood cells and/or platelets. You may notice tiredness, infection (which can be severe), fever, feeling short 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 some substances in the blood (for example low sodium and potassium). You may notice muscle weakness, thirst, pins and needles in the skin, muscle cramps or feeling unwell.
• Increased or elevated levels of fats in the blood (including cholesterol).
• Gout.
• Feeling restless.
• Depression.
• Difficulty sleeping.
• Pins and needles sensation.
• Temporary vision problems.
• Eye and vision problems such as “yellow vision” and blurred vision, rapid onset of distance vision reduction (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).
• Feeling of spinning (vertigo).
• Feeling of fainting (especially when standing up).
• Damage to blood vessels causing reddish or purplish spots on the skin.
• Difficulty breathing. You may feel short of breath if the lungs become inflamed or have fluid in them.
• 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 caused by sensitivity to sunlight, rash, severe rash that develops 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 can 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, 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 LISINOPRIL and IDROCLOROTIAZIDE DOC Generici

Keep this medicine out of sight and reach of children.
Do not store at a temperature above 25°C.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LISINOPRIL and IDROCLOROTIAZIDE DOC Generici contains

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

Description of the appearance of LISINOPRIL and IDROCLOROTIAZIDE DOC Generici and content
of the pack
White, round tablets, with LH imprinted on one side.

Packs:
PVC/PVDC-Al blisters: 14 and 28 tablets.
PP container: 30 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy: LISINOPRIL and IDROCLOROTIAZIDE DOC Generici