Parapres plus 16 mg/12,5 mg comprimidos

Prospect: information for the user

Parapres Plus 16 mg/12.5 mg tablets

candesartán cilexetilo / hidroclorotiazida

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Parapres Plus and what it is used for

2.What you need to know before starting to take Parapres Plus

3.How to take Parapres Plus

4.Possible adverse effects

5.Storage of Parapres Plus

6.Contents of the package and additional information

Your medication is called Parapres Plus. It is used for the treatment of high blood pressure (hypertension). It contains two active ingredients: candesartan cilexetilo and hydrochlorothiazide. Both work together to lower blood pressure.

• Candesartan cilexetilo belongs to a group of medications called angiotensin II receptor antagonists. It causes blood vessels to relax and dilate. This facilitates a decrease in blood pressure.
• Hydrochlorothiazide belongs to a group of medications called diuretics. It promotes the body to eliminate water and salt, such as sodium, in urine. This facilitates a decrease in blood pressure.

Your doctor may prescribe Parapres Plus if your blood pressure has not been adequately controlled with candesartan cilexetilo or hydrochlorothiazide alone.

Do not take Parapres Plus

• if you are allergic to candesartan cilexetilo or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamides. If you are unsure whether you are in this situation, consult your doctor.
• if you are more than 3 months pregnant. (It is also best to avoid Parapres Plus during the early months of pregnancy – see Pregnancy section).
• if you have severe kidney disease.
• if you have a severe liver disease or bile duct obstruction (problem with the bile flowing from the gallbladder).
• if you have persistent low levels of potassium in the blood.
• if you have persistent high levels of calcium in the blood.
• if you have ever had gout.
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If you are unsure whether you are in any of these situations, consult your doctor or pharmacist before taking Parapres Plus.

Warnings and precautions

Consult your doctor before starting to take Parapres Plus,

• if you are diabetic.
• if you have heart, liver or kidney problems.
• if you have recently had a kidney transplant.
• if you have been vomiting, have had it frequently recently or have diarrhea.
• if you have a condition called Conn's syndrome (also known as primary aldosteronism).
• if you have ever had a condition called systemic lupus erythematosus (SLE).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you have had an allergy or asthma.
• if you are taking any of the following medicines used to treat high blood pressure:

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from the sun and UV rays while taking Parapres Plus.
• if you experience a decrease in vision or eye pain. This could be a symptom of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and may occur within a few hours to weeks after taking Parapres Plus. This can lead to permanent vision loss if not treated. If you have previously had an allergy to sulfonamide or penicillin, you may have a higher risk of developing this.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Parapres Plus, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting or diarrhea after taking Parapres Plus. Your doctor will decide whether to continue treatment. Do not stop taking Parapres Plus on your own.

Your doctor may monitor your kidney function, blood pressure and electrolyte levels (such as potassium) in the blood at regular intervals.

See also the information in the section “Do not take Parapres Plus”

Inform your doctor if you are pregnant (or if you suspect you may be). Parapres Plus is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards (see Pregnancy section).

If you are in any of these situations, your doctor may want to see you more frequently and perform some tests.

If you are undergoing surgery, inform your doctor or dentist that you are taking Parapres Plus. This is because Parapres Plus, in combination with some anesthetics, may cause a drop in blood pressure.

Parapres Plus may increase your skin's sensitivity to the sun.

Children

There is no experience with the use of Parapres Plus in children (under 18 years). Therefore, Parapres should not be administered to children.

Other medicines and Parapres Plus

Inform your doctor or pharmacist if you are using, have used or may need to use any other medicine.

Parapres Plus may affect how some medicines work and some medicines may affect the effect of Parapres Plus. If you are taking certain medicines, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are taking any of the following medicinesas your doctor may need to change your dose and/or take other precautions:

• other medicines to lower your blood pressure, including beta-blockers, diazoxide and the so-called ACE inhibitors such as enalapril, captopril, lisinopril or ramipril.
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines to relieve pain and inflammation).
• aspirin (if you take more than 3 g per day) (medicines to relieve pain and inflammation).
• potassium supplements or salt substitutes containing potassium (medicines to increase potassium levels in the blood).
• calcium supplements or vitamin D.
• medicines to reduce cholesterol, such as colestipol or cholestyramine.
• medicines for diabetes (tablets or insulin).
• medicines to control heart rhythm (antiarrhythmic agents) such as digoxin and beta-blockers.
• medicines that may be affected by potassium levels in the blood, such as some antipsychotic medicines.
• heparin (a medicine to increase blood fluidity).
• diuretics (medicines to promote urine excretion).
• laxatives.
• penicillin (an antibiotic).
• amphotericin (for the treatment of fungal infections).
• lithium (a medicine for mental health problems).
• steroids such as prednisolone.
• pituitary hormone (ACTH).
• medicines for cancer treatment.
• amantadine (for the treatment of Parkinson's disease or severe viral infections).
• barbiturates (a type of sedative, also used to treat epilepsy).
• carbenoxolone (for the treatment of esophageal disease or oral ulcers).
• anticholinergic agents such as atropine and biperiden.
• ciclosporin, a medicine used for organ transplants, to prevent organ rejection.
• other medicines that may increase the antihypertensive effect, such as baclofen (a medicine for muscle spasms), amifostine (used in cancer treatment) and some antipsychotic medicines.
• if you are taking an ACE inhibitor or aliskiren (see also the information in the sections “Do not take Parapres Plus” and “Warnings and precautions”)

Parapres Plus with food, drinks and alcohol

• You can take Parapres Plus with or without food.
• When you are prescribed Parapres Plus, consult your doctor before taking alcohol. Alcohol may cause dizziness or fainting.

Pregnancy, breastfeeding and fertility

Pregnancy

You must inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking Parapres Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend taking another medicine instead of Parapres Plus. Parapres Plus is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered from the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start. Parapres Plus is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

Some patients may feel tired or dizzy when taking Parapres Plus. If this happens to you, do not drive or operate tools or machines.

Parapres Plus contains lactose

Lactose is a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Use in athletes: This medicine contains hydrochlorothiazide, which may produce a positive result in doping control tests.

Follow exactly the administration instructions for Parapres Plus as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

It is essential to continue taking Parapres Plus every day.

The usual dose is one tablet per day.

Swallow the tablet with a glass of water.

Try to take the tablet at the same time every day. This will help you remember to take it.

The tablet can be divided into equal doses.

If you take more Parapres Plus than you should

If you have taken more Parapres Plus than prescribed by your doctor, contact your doctor or pharmacist immediately. You can also consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Parapres Plus

Do not take a double dose to compensate for the missed doses. Simply take the next dose.

If you interrupt treatment with Parapres Plus

If you stop taking Parapres Plus, your blood pressure may increase again. Therefore, do not stop taking Parapres Plus before consulting your doctor.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, Parapres Plus may cause side effects, although not everyone will experience them.

It is essential that you know which side effects could occur. Some side effects of Parapres Plus are due to candesartan cilexetil, and others are due to hydrochlorothiazide.

Stop taking Parapres Plus and see your doctor immediately if you experience any of the following allergic reactions:

• Difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat.
• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing.
• Severe skin itching (with skin rash).

Parapres Plus may cause a decrease in white blood cells. Your resistance to infections may decrease, and you may feel tired, have an infection, or fever. If this occurs, inform your doctor. Your doctor may perform blood tests from time to time to check if Parapres Plus is affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (affects 1 to 10 patients out of every 100)

• Changes in blood test results:

• A reduction in sodium levels in the blood. If severe, you may feel weak, lack energy, or have muscle cramps.
• An increase or decrease in potassium levels in the blood, especially if you have kidney problems or heart failure. If severe, you may feel tired, weak, have irregular heartbeats, or experience numbness.
• An increase in cholesterol, glucose, or uric acid levels in the blood.

• Presence of glucose in urine.
• Sensation of dizziness or weakness.
• Headache.
• Respiratory infection.

Rare (affects fewer than 1 in 100 patients)

• Low blood pressure. This may cause dizziness or fainting.
• Loss of appetite, diarrhea, constipation, stomach irritation.
• Skin rash, hives, skin reaction caused by sensitivity to sunlight.

Very rare (affects fewer than 1 in 1,000 patients)

• Icterus (yellowing of the skin and white of the eyes).If this occurs, contact your doctor immediately.
• Effects on kidney function, especially if you have kidney problems or heart failure.
• Difficulty sleeping, depression, or restlessness.
• Itching or prickling sensations in arms and legs.
• Blurred vision for a short period.
• Abnormal heartbeats.
• Difficulty breathing (including pulmonary inflammation and fluid in the lungs).
• Fever.
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels that produce red or purple spots on the skin.
• Decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, fever, or easily bruise.
• Severe skin reaction that develops rapidly, causing blisters and skin peeling, and possibly mouth ulcers.
• Worsening of pre-existing lupus erythematosus reactions or appearance of rare skin reactions.

Very rare (affects fewer than 1 in 10,000 patients)

• Intestinal angioedema: swelling in the intestine, which may cause symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• Swelling of the face, lips, tongue, and/or throat.
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).
• Itching.
• Back pain, joint pain, and muscle pain.
• Changes in liver function, including inflammation of the liver (hepatitis). You may feel tired, have yellowing of the skin and white of the eyes, and experience flu-like symptoms.
• Cough.
• Nausea.

Unknown (cannot be estimated based on available data)

• Sudden nearsightedness.
• Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).
• Skin and lip cancer (non-melanoma skin cancer).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children.
• No special storage conditions are required.
• Do not use Parapres Plus after the expiration date shown on the packaging or blister. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Parapres Plus

• Parapres Plus tablets contain the following active ingredients: candesartan cilexetil and hydrochlorothiazide. The tablets contain 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other components are: calcium carbonate, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, cornstarch, macrogol, and iron oxide (E172).

Appearance of the product and contents of the packaging

Parapres Plus is presented in the form of pale pink, oval, flat tablets, approximately 8.5 mm by 5.1 mm, with a groove and the imprint 16 / C on both sides.

Parapres Plus 16 mg/12.5 mg tablets are presented in a single-dose blister packaging in containers of 28 or 300 tablets.

Not all packaging sizes may be marketed in all countries.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre nº 151

08022 - Barcelona (Spain)

Responsible manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

or

Takeda Ireland Ltd.

Bray Business Park - Kilruddery - Co.Wicklow (Ireland)

or

Delpharm Novara S.r.l.

Via Crosa, 86 28065 Cerano (No) – Italy

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: January 2025.

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(https://www.aemps.gob.es/)