Ratipred

Ratipred 150 mg/12.5 mg film-coated tablets
Ratipred 300 mg/12.5 mg film-coated tablets
Ratipred 300 mg/25 mg film-coated tablets
irbesartan and hydrochlorothiazide
equivalent medicine
Please 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ratipred is and what it is used for

Ratipred is a combination of two active substances: irbesartan and hydrochlorothiazide.
Irbesartan belongs to a group of medicines called angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to its receptors located in blood vessels, causing them to narrow. This leads to an increase in blood pressure. By binding to angiotensin-II receptors, irbesartan causes blood vessels to dilate, thereby lowering blood pressure.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which increase urine production, resulting in a reduction of blood pressure.
The two active substances in Ratipred work together to lower blood pressure more effectively than when either is administered alone.
Ratipred is used to treat high blood pressure (hypertension) in adults when treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled blood pressure.

2. What you should know before taking Ratipred

Do not take Ratipred

• if you are allergic to the active substances (irbesartan and hydrochlorothiazide) or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to any medicines derived from sulfonamides; in this case, ask your doctor if you are unsure;
• if you are more than 3 months pregnant (it is better to avoid taking Ratipred even in the early stages of pregnancy – see section “Pregnancy”);
• if you have severe liver or kidney problems;
• if you have difficulty urinating;
• if you have a condition associated with persistently high calcium levels or low potassium levels in the blood, as diagnosed by your doctor;
• 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 Ratipred.
Consult your doctor if you are in any of the following situations:

• if you have excessive vomiting or diarrhea;
• if you have kidney problems or have had a kidney transplant;
• if you have heart problems;
• if you have liver problems;
• if you have diabetes;
• if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid or pounding heartbeat), especially if you are being treated for diabetes;
• if you have systemic lupus erythematosus (also known as lupus or SLE), a chronic autoimmune disease causing joint pain, skin rashes, and fever;
• if you have primary hyperaldosteronism, a condition caused by excessive production of the hormone aldosterone, leading to sodium retention and consequently high blood pressure;
• if you are taking any of the following medicines for high blood pressure: or an “ACE inhibitor” (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes; or 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 exposure and UV radiation while taking Ratipred;
• if you have previously experienced breathing or lung problems (including lung inflammation or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Ratipred, consult a doctor immediately.

Contact your doctor if, after taking Ratipred, you experience abdominal pain, nausea, vomiting, or diarrhea.
Your doctor will decide whether treatment should continue. Do not stop taking Ratipred on your own.
Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium in the blood) at regular intervals (see section “Do not take Ratipred”).
Inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Ratipred is not recommended during early pregnancy and must not be used if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section “Pregnancy”).
Also, inform your doctor:

• if you are on a low-salt diet;
• if you experience symptoms such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or a very rapid heartbeat, which may indicate an excessive effect of hydrochlorothiazide (active ingredient in Ratipred);
• if you notice an unusually rapid increase in skin sensitivity to sunlight, with symptoms of sunburn (such as redness, itching, swelling, or skin rash);
• if you are scheduled for surgery or need to take anesthetics;
• if you experience vision loss or eye pain. These could 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 several weeks after taking Ratipred. If untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this condition. In such cases, stop taking Ratipred and consult your doctor immediately.

Hydrochlorothiazide, contained in this medicine, may cause a positive result in anti-doping tests.

Children and adolescents
Ratipred must not be given to children and adolescents under 18 years of age.

Other medicines and Ratipred
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may consider it necessary to adjust the dose and/or take additional precautions if:

• you are taking an ACE inhibitor or aliskiren (see also section “Do not take Ratipred” and “Warnings and precautions”). Diuretics such as hydrochlorothiazide, contained in Ratipred, may interact with other medicines. Medicines containing lithium, used to treat mental illnesses, must not be taken together with Ratipred unless under strict medical supervision.

Consult your doctor, as you may need blood tests if you are taking:

• potassium supplements;
• salt substitutes containing potassium;
• potassium-sparing diuretics or other diuretics (medicines that help produce urine);
• certain laxatives (medicines that promote bowel evacuation);
• medicines for gout, an inflammatory joint disease causing pain and swelling;
• vitamin D supplements;
• medicines to control heart rhythm;
• medicines for diabetes (oral antidiabetics or insulin);
• carbamazepine, a medicine used to treat epilepsy.

Inform your doctor if you are taking other medicines to lower blood pressure, medicines for inflammation (steroids), cancer treatments, painkillers, medicines for joint inflammation (arthritis), or colestyramine and colestipol, medicines used to reduce blood fat (cholesterol) levels.

Ratipred with food and drink
Ratipred can be taken with or without food.
Due to the hydrochlorothiazide contained in Ratipred, if you drink alcohol while taking this medicine, you may feel more dizzy when standing up, especially when moving from a sitting to a standing position.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might 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 advise you to stop taking Ratipred before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine. Ratipred is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child at this stage.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Ratipred is not recommended during breastfeeding. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
It is unlikely that Ratipred will affect your ability to drive or operate machinery. However, occasionally, dizziness or fatigue may occur during treatment for high blood pressure. If this happens, consult your doctor before driving or operating machinery.

Ratipred contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Ratipred contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

For those engaged in sports
Due to the hydrochlorothiazide contained in Ratipred, using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

3. How to take Ratipred
Always take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage
The recommended dose of Ratipred is:
1 or 2 tablets daily. Your doctor will prescribe Ratipred if your previous treatment has not sufficiently lowered your blood pressure. Your doctor will advise you on how to switch from your previous treatment to Ratipred.

Method of administration
Ratipred is for oral use.
Swallow the tablets with sufficient liquid (e.g., a glass of water). You may take Ratipred with or without food. Try to take the medicine at the same time each day. It is important to continue treatment unless otherwise instructed by your doctor.
The maximum blood pressure-lowering effect is achieved after 6–8 weeks of starting treatment.

Use in children and adolescents
Ratipred must not be given to children under 18 years of age.

If you take more Ratipred than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.

If you forget to take Ratipred
Do not take a double dose to make up for the missed dose. If you forget to take a dose of Ratipred, continue your treatment as usual.

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 will experience them.
Some of these effects may be serious and may require medical attention.
In patients treated with irbesartan, rare cases of allergic skin reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported.
If you experience any of the above symptoms or have difficulty breathing, stop taking Ratipred and contact your doctor immediately.

The side effects reported in patients treated with Ratipred are:

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

• nausea/vomiting;
• urinary tract disorders;
• fatigue;
• dizziness (also when changing from a sitting or lying position to standing);
• blood tests may show an increase in the level of an enzyme that measures muscle and heart function (creatine kinase), or an increase in substances measuring kidney function (azotemia, creatinine).

Uncommon (may affect up to 1 in 100 people):

• diarrhoea;
• low blood pressure (hypotension);
• rapid heartbeat;
• orthostatic dizziness (when changing from sitting or lying down to standing);
• hot flushes;
• swelling;
• sexual dysfunction (problems with sexual activity);
• blood tests may show decreased levels of potassium and sodium in the blood.

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

• intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Side effects with frequency not known (cannot be estimated from the available data):

• headache;
• annoying noises and ringing in the ears (tinnitus);
• cough;
• altered taste;
• indigestion;
• joint and muscle pain;
• altered liver and kidney function;
• high levels of potassium in the blood;
• allergic reactions (rash, urticaria, localized swelling of the face, lips, mouth, tongue or throat);
• jaundice (yellowing of the skin and/or whites of the eyes).

As with any combination of two active substances, side effects associated with each component cannot be excluded.

Side effects associated with irbesartan alone
In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock), reduced number of red blood cells (anaemia - symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness and paleness), and reduced platelet count (blood cells essential for blood clotting) have also been reported.

Side effects associated with hydrochlorothiazide alone:

• loss of appetite;
• stomach irritation;
• stomach cramps;
• constipation;
• jaundice (yellowing of the skin and/or whites of the eyes);
• inflammation of the pancreas characterized by severe pain in the upper abdomen, often with nausea and vomiting;
• sleep disorders;
• depression;
• blurred vision;
• lack of white blood cells, which may lead to frequent infections and fever;
• reduced platelet count (an essential component for blood clotting), reduced red blood cell count (anaemia) characterized by fatigue, headache, shortness of breath during exercise, dizziness and paleness;
• kidney disorders;
• lung problems including inflammation of the lungs (pneumonitis) or fluid accumulation in the lungs;
• increased sensitivity of the skin to sunlight;
• inflammation of blood vessels;
• a skin disorder characterized by peeling of the skin over the entire body;
• lupus erythematosus, a chronic disease of the body's immune system causing joint pain, skin rashes and fever;
• allergic reactions;
• muscle weakness and spasms;
• paraesthesia (altered sensation in limbs or other body parts);
• irregular heartbeat;
• drop in blood pressure upon changing body position;
• swelling of the salivary glands;
• high blood sugar levels;
• sugar in the urine;
• increases in certain types of blood fats;
• elevated levels of uric acid in the blood, which may cause gout, an inflammatory joint disease causing pain and swelling;
• Very rare (may affect up to 1 in 10,000 people): acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness and confusion).

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

It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

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 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 Ratipred

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 packaging after "Exp.". The expiry
date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from light and moisture.
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 Ratipred contains

• The active substances are irbesartan and hydrochlorothiazide. Each tablet of Ratipred 150 mg/12.5 mg contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Each tablet of Ratipred 300 mg/12.5 mg contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Each tablet of Ratipred 300 mg/25 mg contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
• The other components of the 150 mg/12.5 mg and 300 mg/12.5 mg tablets are: microcrystalline cellulose, pregelatinized starch, lactose monohydrate, Poloxamer 188, sodium croscarmellose, magnesium stearate, hypromellose 6cp, titanium dioxide, purified stearic acid, yellow iron oxide, red iron oxide.
• The other components of the 300 mg/25 mg tablets are: microcrystalline cellulose, pregelatinized starch, lactose monohydrate, Poloxamer 188, sodium croscarmellose, magnesium stearate, hypromellose 6cp, titanium dioxide, purified stearic acid, red iron oxide, black iron oxide.

Description of Ratipred and contents of the pack
Pack of 28 tablets in blister.
Marketing Authorization Holder and manufacturer
Marketing Authorization Holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A. Contrada Canfora 84084 – Fisciano (SA)