Ipersart

Package Leaflet: Information for the User

IPERSART 50 mg/12.5 mg film-coated tablets, 100 mg/25 mg film-coated tablets

Losartan potassium/Hydrochlorothiazide
Equivalent 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 adverse reactions, including those not listed in this leaflet, contact 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 taking 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 IPERSART is and what it is 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 should know before taking 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, certain antibacterial drugs such as cotrimoxazole; consult your doctor if you have any doubts).
• If your liver function is severely impaired.
• If you are more than 3 months pregnant (it is better to avoid taking IPERSART even during early pregnancy; see the section on pregnancy).
• If your kidney function is severely impaired or your kidneys are not producing urine.
• If you have low levels of potassium or sodium, or high levels of calcium that cannot be corrected with treatment.
• If you suffer from gout.
• If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

• if you have previously experienced swelling of the face, lips, throat, or tongue.
• If you are taking diuretics (medicines that help eliminate fluids).
• If you are on a low-salt diet.
• If you are currently experiencing or have recently 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), only one functioning kidney, or have recently undergone a kidney transplant.
• If you have arterial narrowing (atherosclerosis), angina pectoris (chest pain due to reduced heart function).
• If you have "aortic or mitral valve stenosis" (narrowing of heart valves) or "hypertrophic cardiomyopathy" (a disease causing thickening of the heart muscle).
• If you are diabetic.
• If you have suffered from gout.
• If you have or have previously had an allergic condition, asthma, or a disease causing joint pain, skin rashes, and fever (systemic lupus erythematosus).
• If you have high calcium levels or low potassium levels, or if you are on a potassium-poor diet.
• If you are due to receive an anesthetic (even from the dentist) or before surgery, or if you are undergoing tests to assess parathyroid function, you must inform your 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 due to a glandular abnormality).
• If you are taking any of the following medicines used to treat high blood pressure:
  • An ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • Aliskiren.
• If you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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 sun and UV exposure while taking IPERSART.
• If you experience vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to weeks after starting IPERSART. This could lead to permanent vision loss if not treated. If you have previously had an allergic reaction to penicillin or sulfonamides, you may be at higher risk of developing this condition.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the information in the section “Do not take IPERSART”.
If you think you may be pregnant (or if there is a possibility of becoming pregnant), you must inform your doctor. IPERSART is not recommended during early pregnancy and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to the unborn child if used at this stage (see the section on pregnancy).

Children and adolescents
There is no experience with the use of IPERSART in children. Therefore, IPERSART must not be administered to children.

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

Other medicines and IPERSART
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Diuretic agents such as hydrochlorothiazide contained in IPERSART may interact with other medicines.
Lithium-containing preparations must not be taken with IPERSART without careful medical supervision.
Special precautionary measures (e.g. blood tests) may be necessary if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, other diuretics (medicines that help eliminate fluids), certain laxatives, glycyrrhizin (found in licorice), medicines for gout, medicines to control heart rhythm, or medicines for diabetes (oral agents or insulin).
Your doctor may need to adjust the dose and/or take other precautions:

• if you are taking an ACE inhibitor or aliskiren (see also the information in sections “Do not take IPERSART” and “Warnings and precautions”). It is important that you inform your doctor if you are also taking:
  • other medicines to lower blood pressure
  • steroids
  • medicines for treating tumors
  • analgesics
  • medicines for treating fungal infections
  • medicines for arthritis
  • resins used to treat high cholesterol, such as cholestyramine
  • muscle relaxants
  • sleeping medicines
  • opioid medicines such as morphine
  • "pressor amines" such as adrenaline or other medicines of the same class.

Inform your doctor that you are taking IPERSART if you are scheduled for a radiographic procedure involving administration of an iodinated contrast agent.

IPERSART with food, drinks, and alcohol
It is advisable not to drink alcohol while taking these tablets: alcohol and IPERSART tablets may increase each other's effects.
Excessive intake of dietary salt may counteract the effect of IPERSART tablets.
IPERSART tablets 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
If you think you may be pregnant (or if there is a possibility of becoming pregnant), you must inform your doctor. Your doctor will generally advise you to stop taking IPERSART before starting a pregnancy or as soon as you realize you are pregnant, and will recommend an alternative medicine to IPERSART. IPERSART is not recommended during pregnancy and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to the unborn child if used beyond the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. IPERSART is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

Driving and using machines
When you start treatment with this medicine, do not perform tasks requiring special attention (e.g. driving a car or operating dangerous machinery) until you know how you react to the medicine.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

IPERSART contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially sodium-free.

3. How to take IPERSART

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor.
Your doctor will determine the appropriate dose of IPERSART based on your medical condition and any
other medicines you may be taking. It is important that you continue taking IPERSART for as long as
your doctor instructs, in order to maintain consistent control of your 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 once daily to control blood pressure over a 24-hour period. This dose may be increased to 2 film-coated tablets of
losartan/hydrochlorothiazide 50 mg/12.5 mg once daily, or you may switch to 1 film-coated tablet of losartan/hydrochlorothiazide 100 mg/25 mg daily (a higher strength). The maximum daily dose is 2 film-coated tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg once daily or 1 film-coated tablet of losartan/hydrochlorothiazide 100 mg/25 mg daily.
If you take more IPERSART than you should
In case of overdose, contact your doctor immediately so that appropriate medical care can be provided.
An overdose may cause low blood pressure, palpitations, slowed heart rate, 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 regular dosing schedule.
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 following problems, stop taking IPERSART tablets and contact your doctor immediately or go to the nearest hospital:
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing).
This is a serious but rare side effect, which may affect up to 1 in 1,000 people. Urgent medical attention or hospitalization may be required.

The following side effects have been reported:

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

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, nasal 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 may cause abnormal heart rhythm), reduced 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 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 overt gout, increased blood sugar levels, abnormal blood electrolyte levels.
• Anxiety, nervousness, panic disorder (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory impairment.
• Tingling or similar sensations, pain in the extremities, tremor, migraine, fainting.
• Blurred vision, burning or stabbing eye pain, conjunctivitis, worsening of vision, yellow vision.
• Ringing, buzzing, roaring or clicking in the ears.
• Low blood pressure, which may be associated with postural changes (dizziness or weakness when standing up), angina (chest pain), abnormal 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, fluid in the lungs (causing breathing difficulties), nosebleeds, runny nose, congestion.
• Constipation, flatulence, gastric problems, gastric spasms, vomiting, dry mouth, inflammation of the salivary glands, toothache.
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas.
• Urticaria, itching, skin inflammation, rash, skin redness, photosensitivity, dry skin, hot flushes, sweating, hair loss.
• Pain in arms, shoulders, hips, knees or other joints, joint swelling and stiffness, muscle weakness.
• Frequent need to urinate, including at night, abnormal kidney function, including kidney inflammation, urinary tract infection, presence of sugar in urine.
• Decreased sexual desire, impotence.
• Facial swelling, fever.
• Low sodium levels in the blood (hyponatraemia).

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

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

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

• Influenza-like symptoms
• Unexplained muscle pain with dark urine (rhabdomyolysis)
• General feeling of being unwell
• Taste disturbances (dysgeusia)
• Cutaneous lupus erythematosus (characterised by skin rash/erythema on areas of skin exposed to light)
• Skin and lip cancer (non-melanoma skin cancer)
• Decreased vision or eye pain due to increased 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 experience any side effect, including those not listed in this leaflet, please inform your doctor. You can also report side effects directly via 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 carton after "EXP". The expiry date refers to the last day of that month.
Blister:
store below 25 °C.
Do not dispose of medicines 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 IPERSART contains

• The active substances 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 components are:
  • Tablet core: mannitol (E421), microcrystalline cellulose, sodium croscarmellose, povidone (K-30), magnesium stearate.
  • Film coating: hypromellose (3cP, 50cP), hydroxypropylcellulose, titanium dioxide (E171), macrogol 400.

Description of the appearance of IPERSART and contents of the pack
IPERSART 50 mg/12.5 mg tablets are white, round, biconvex, film-coated tablets, 8 mm in diameter, with a score line on both sides and lateral indentations. On one side they are marked with “LH1”.
IPERSART 100 mg/25 mg tablets are white, round, biconvex, film-coated tablets, 10 mm in diameter, with a score line on both sides and lateral indentations. On one side they are marked with “LH2”.
Blister packs:
Blister packs: 28 film-coated tablets.

Marketing Authorization 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