IPERSART 50 mg /12.5 Mg Film-Coated Tablets

Зміст інструкції

1. IPERSART 50 mg/12,5 mg film-coated tablets, 100 mg/25 mg film-coated tablets
   1. What is IPERSART and what is it used for
   2. What you need to know before you take IPERSART
   3. How to take IPERSART
   4. Possible side effects
   5. How to store IPERSART
   6. Contents of the pack and other information

IPERSART 50 mg/12,5 mg film-coated tablets, 100 mg/25 mg film-coated tablets

Losartan potassium/Hydrochlorothiazide
Generic medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is IPERSART and what is it used for

IPERSART is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic
(hydrochlorothiazide).
IPERSART is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before you take IPERSART

Do not take IPERSART

• If you are allergic to losartan, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other sulfonamide-derived substances (e.g. other thiazides, some antibacterial drugs such as cotrimoxazole, ask your doctor if you have any doubts).
• If your liver function is severely impaired.
• If you are pregnant for more than 3 months (it is best to avoid taking IPERSART even in the early stages of pregnancy; see the section on pregnancy).
• If your kidney function is severely impaired or your kidneys do not produce urine.
• If you have low levels of potassium or sodium or high levels of calcium that cannot be corrected with therapy.
• If you suffer from gout.
• If you have diabetes or impaired kidney function and are being treated with a medicine that lowers blood pressure containing aliskiren.

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

• if you have experienced swelling of the face, lips, tongue or throat in the past.
• If you are taking diuretics (medicines that help to eliminate fluids).
• If you are following a diet with limited salt intake.
• If you have or have had severe episodes of vomiting and/or diarrhea.
• If you suffer from heart failure.
• If you have narrowing of the arteries leading to the kidneys (renal artery stenosis) or if you have only one functioning kidney or have recently had a kidney transplant.
• If you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to reduced heart function).
• If you have “aortic or mitral valve stenosis” (narrowing of the heart valves) or “hypertrophic cardiomyopathy” (a disease that causes thickening of the heart muscle).
• If you are diabetic.
• If you have suffered from gout.
• If you have or have had a problem with allergy, asthma or a disease that causes joint pain, skin rashes and fever (systemic lupus erythematosus).
• If you have high levels of calcium or low levels of potassium or are following a low-potassium diet.
• If you are to receive an anesthetic (even from the dentist) or before surgery, or if you are to undergo tests to check the function of the parathyroid glands, you must inform the doctor or medical staff that you are taking losartan potassium and hydrochlorothiazide tablets.
• If you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal glands, caused by an abnormality of the glands).
• If you are taking any of the following medicines used to treat high blood pressure.
• An ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have 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, may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking IPERSART.
• If you have blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within hours to weeks of taking IPERSART. This could lead to permanent vision loss if left untreated. If you have previously had an allergic reaction to penicillin or sulfonamides, you may be at higher risk of developing this.

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 the information in the section “Do not take IPERSART”.
If you believe you may be pregnant (or if there is a possibility of becoming pregnant) you should
inform your doctor. IPERSART is not recommended in the early stages of pregnancy and should not be
taken after the first 3 months of pregnancy, as it can cause serious harm to the baby (see the section on pregnancy).

Children and adolescents
There is no experience with the use of IPERSART in children. IPERSART should therefore not be
given to children.

Use in the elderly
The action of IPERSART is equally effective and well tolerated in most elderly and younger adult
patients. In most elderly patients the dose required is the same as in younger patients.

Other medicines and IPERSART
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Diuretics such as hydrochlorothiazide contained in IPERSART can interact with other medicines.
Lithium preparations should not be taken with IPERSART without careful medical supervision.
It may be appropriate to take special precautions (e.g. blood tests) if you are taking potassium supplements, potassium-containing salt substitutes or potassium-sparing drugs, other diuretics (medicines that help to eliminate fluids), some laxatives, glycyrrhiza (found in
licorice) medicines for the treatment of gout, medicines to control heart rhythm or for
diabetes (oral agents or insulin).
The doctor may need to change the dose and/or take other precautions:

• if you are taking an ACE inhibitor or aliskiren (see also the information in the sections “Do not take IPERSART” and “Warnings and precautions”) It is important that you also tell your doctor if you are taking:
• other medicines to lower blood pressure
• steroids
• medicines for the treatment of cancer
• pain relievers
• medicines for the treatment of fungal infections
• medicines for arthritis
• resins used to treat high cholesterol, such as cholestyramine
• medicines that relax muscles
• sleeping pills
• opioid medicines such as morphine
• “pressor amines” such as adrenaline or other medicines of the same group.

Tell your doctor that you are taking IPERSART if you are to undergo a radiographic procedure
involving the administration of an iodine-containing contrast agent.

IPERSART with food, drinks and alcohol
It is advisable not to drink alcohol while taking these tablets: alcohol and IPERSART tablets
can increase each other's effects.
Excessive intake of table salt can counteract the effect of IPERSART tablets.
IPERSART tablets can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
If you believe you may be pregnant (or if there is a possibility of becoming pregnant) you should
inform your doctor. The doctor will generally advise you to stop taking IPERSART before
starting a pregnancy or as soon as you realize you have started one and will advise you to take another
medicine instead of IPERSART. IPERSART is not recommended during pregnancy and should not be
taken after the first 3 months of pregnancy, as it can cause serious harm to the baby if used after the
third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. IPERSART is not recommended for
breastfeeding mothers and your doctor may choose another treatment for you if you wish to breastfeed.

Driving and operating machinery
When you start treatment with this medicine, you should not perform tasks that may require
particular attention (e.g. driving a car or using dangerous machinery) until you know how you tolerate the medicine.
For those who engage in sports: the use of the drug without a therapeutic need constitutes doping and
may still result in positive doping tests.
IPERSART contains less than 1 mmol (23 mg) of sodium per dose, which is essentially sodium-free.

3. How to take IPERSART

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor.
Your doctor will establish the appropriate dose of IPERSART, based on your medical condition and any
other medicines you are taking. It is important that you continue to take IPERSART for as long as
your doctor tells you to, in order to maintain constant control of blood pressure.

High blood pressure
The recommended dose of IPERSART for most patients with high blood pressure is 1
tablet of IPERSART 50 mg/12.5 mg per day to control blood pressure for a period of
24 hours. This dose may be increased and brought to 2 film-coated tablets of
losartan/hydrochlorothiazide 50 mg/12.5 mg once a day or you may switch to 1 film-coated
tablet of losartan/hydrochlorothiazide 100 mg/25 mg per day (a higher concentration). The
maximum daily dose is 2 film-coated tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg once a
day or 1 film-coated tablet of losartan/hydrochlorothiazide 100 mg/25 mg per day.

If you take more IPERSART than you should
In case of overdose, contact your doctor immediately to receive appropriate
medical attention. An overdose may cause a drop in blood pressure, palpitations, a slowing of the
pulse, changes in blood composition and dehydration.

If you forget to take IPERSART
Try to take IPERSART every day, as prescribed. Do not take a double dose to make up for a
missed dose.
Simply resume your usual dosing schedule.
If you have any doubts about the use of the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following problems, stop taking IPERSART tablets and inform your
doctor immediately or go to the nearest hospital:
A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth or
throat that can cause difficulty swallowing or breathing).
This is a serious but rare side effect, which can affect up to 1 in 1,000 people. Urgent medical attention or hospitalisation
may be necessary.
The following side effects have been reported:

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

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorders.
• Diarrhoea, abdominal pain, nausea, indigestion.
• Muscle pain or cramps, leg pain, back pain.
• Insomnia, headache, dizziness.
• Weakness, fatigue, chest pain.
• Increased potassium levels (which can cause an irregular heartbeat), decreased haemoglobin levels.
• Changes in kidney function including renal failure.
• Low blood sugar levels (hypoglycaemia). Uncommon (may affect up to 1 in 100 people):
• Anaemia, red or brownish-purple spots on the skin (sometimes particularly on the feet, legs, arms and buttocks, with joint pain, swelling of hands and feet and stomach pain), bruising, reduced number of white blood cells and problems with blood clotting.
• Loss of appetite, increased uric acid levels or gout, increased blood sugar levels, abnormal electrolyte levels in the blood.
• Anxiety, nervousness, panic disorder (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, impaired memory.
• Tingling or similar sensations, pain in the extremities, tremor, migraine, fainting.
• Blurred vision, burning or stinging in the eyes, conjunctivitis, worsening of vision, yellowing of vision.
• Whistling, ringing, buzzing or clicking in the ears.
• Low blood pressure, which may be associated with changes in posture (feeling dizzy or weak when getting up, angina (chest pain), irregular heartbeat, stroke (TIA, “mini-stroke”), heart attack, palpitations.
• Inflammation of blood vessels, often associated with skin rash or bruising.
• Sore throat, shortness of breath, bronchitis, pneumonia, water in the lungs (causing difficulty breathing), nosebleeds, runny nose, congestion.
• Constipation, intestinal gas, stomach problems, stomach cramps, vomiting, dry mouth, inflammation of the salivary glands, toothache.
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas.
• Urticaria, itching, skin inflammation, skin rash, skin redness, sensitivity to light, dry skin, hot flushes, sweating, hair loss.
• Pain in the arms, shoulders, hips, knees or other joints, joint swelling and stiffness, muscle weakness.
• Frequent need to urinate, even at night, abnormal kidney function, including inflammation of the kidneys, urinary tract infection, presence of sugar in the urine.
• Decreased libido, impotence.
• Swelling of the face, fever.
• Low sodium levels in the blood (hyponatraemia).

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

• Hepatitis (inflammation of the liver), abnormal results in liver function tests.

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

• Flu-like symptoms
• Unexplained muscle pain with dark urine (rhabdomyolysis)
• General feeling of being unwell
• Taste disturbances (dysgeusia)
• Cutaneous lupus erythematosus (characterised by rash/erythema on skin areas exposed to light)
• Skin and lip cancer (non-melanoma skin cancer)
• 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).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system
at www.aifa.gov.it/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 IPERSART

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 label and on the packaging, after
“EXP”. The expiry date refers to the last day of that month.

Blister:
store at a temperature below 25 °C.
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 IPERSART contains

• The active ingredients are losartan potassium and hydrochlorothiazide. Each IPERSART 50 mg/12.5 mg tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Each IPERSART 100 mg/25 mg tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide.
• The other ingredients are:
• Tablet core: mannitol (E421), microcrystalline cellulose, sodium croscarmellose, povidone (K-30), magnesium stearate.
• Film coating: hypromellose (3cP, 50cP), hydroxypropyl cellulose, titanium dioxide (E171), macrogol 400.

Description of the appearance of IPERSART and contents of the pack
IPERSART 50 mg/12.5 mg tablets are film-coated tablets, white, round, biconvex,
8 mm in diameter, with a fracture line on both sides and lateral notches. One side bears the inscription “LH1”.
IPERSART 100 mg/25 mg tablets are film-coated tablets, white, round, biconvex,
10 mm in diameter, with a fracture line on both sides and lateral notches. One side bears the inscription “LH2”.
Pack sizes:
Blisters: 28 film-coated tablets.

Marketing authorisation holder
S.F. GROUP SRL
Via Tiburtina, 1143
00156 Rome
Italy

Manufacturers
Actavis hf.
Reykjavíkurvegur 78, IS-220 Hafnarfjördur
Iceland
Actavis Ltd.
BLB016 Bulebel Industrial
Estate, Zejtun ZTN 3000
Malta