Parapres Plus 16 mg/12.5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Parapres Plus 16 mg/12.5 mg tablets

candesartan cilexetil / hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Your medicine is called Parapres Plus. It is used to treat high blood pressure (hypertension). It contains two active substances: candesartan cilexetil and hydrochlorothiazide. Both work together to lower blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It helps blood vessels to relax and widen, making it easier for blood pressure to decrease.
• Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps the body get rid of water and salts such as sodium through the urine. This also helps reduce blood pressure.

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

2. What you need to know before taking Parapres Plus

Do not take Parapres Plus

• if you are allergic to candesartan cilexetil or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamides. If you are unsure whether this applies to you, consult your doctor.
• if you are more than 3 months pregnant. (Parapres Plus should also be avoided during the first months of pregnancy – see Pregnancy section).
• if you have severe kidney disease.
• if you have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder).
• if you have persistently low levels of potassium in your blood.
• if you have persistently high levels of calcium in your blood.
• if you have ever had gout.
• if you have diabetes or renal insufficiency and are being treated with an antihypertensive medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor before starting Parapres Plus,

• if you have diabetes.

• if you have heart, liver, or kidney problems.

• if you have recently received a kidney transplant.

• if you are experiencing vomiting, have recently vomited frequently, or have diarrhea.

• if you have a disease of the adrenal gland called Conn’s syndrome (also known as primary hyperaldosteronism).

• 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 allergies or asthma.

• 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 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 and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Parapres Plus.

• if you experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks after taking Parapres Plus. This may lead to permanent vision loss if not treated. If you previously had an allergy to sulfonamides or penicillin, you may have a higher risk of developing this condition.

• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking Parapres Plus, seek medical help immediately.

Talk to 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 levels of electrolytes (e.g., potassium) in your blood at regular intervals.

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

Inform your doctor if you are pregnant (or suspect you may be pregnant). Parapres Plus is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby when used from that stage onward (see Pregnancy section).

If any of these situations apply to you, your doctor may want to see you more frequently and carry out certain tests.

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

Parapres Plus may increase skin sensitivity to sunlight.

Children

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

Other medicines and Parapres Plus

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

In particular, inform your doctor if you are taking any of the following medicines, as your doctor may need to adjust your dose and/or take other precautions:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and 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).
• Acetylsalicylic acid (if taking 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 blood).
• Calcium or vitamin D supplements.
• Medicines to lower cholesterol, such as colestipol or cholestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control heart rhythm (antiarrhythmics), such as digoxin and beta-blockers.
• Medicines that may be affected by blood potassium levels, such as certain antipsychotic medicines.
• Heparin (a medicine to increase blood fluidity).
• Diuretics (medicines to promote urine elimination).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (used to treat fungal infections).
• Lithium (a medicine for mental health conditions).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for cancer treatment.
• Amantadine (used to treat Parkinson’s disease or serious viral infections).
• Barbiturates (a type of sedative, also used to treat epilepsy).
• Carbenoxolone (used to treat esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine to relieve muscle spasms), amifostine (used in cancer treatment), and certain antipsychotics.
• If you are taking an ACE inhibitor or aliskiren (see also information in sections “Do not take Parapres Plus” and “Warnings and precautions”).

Taking Parapres Plus with food, drinks, and alcohol

• You may take Parapres Plus with or without food.
• When Parapres Plus is prescribed for you, consult your doctor before drinking alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy, breastfeeding, and fertility

Pregnancy

You must inform your doctor if you are pregnant (or suspect you may be pregnant). Your doctor will usually advise you to stop taking Parapres Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Parapres Plus is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when taken from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Parapres Plus is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you wish to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Parapres Plus contains lactose

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

Use in athletes: this medicine contains hydrochlorothiazide, which may result in a positive doping test.

3. How to take Parapres Plus

Follow exactly the instructions for the administration of Parapres Plus provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

It is important that you continue taking Parapres Plus every day.

The usual dose is one tablet once daily.

Swallow the tablet with a glass of water.

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

The tablet may 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 may also contact the Toxicology Information Service at telephone number 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 make up for missed doses. Simply take the next dose as scheduled.

If you stop taking Parapres Plus

If you stop taking Parapres Plus, your blood pressure may rise again. Therefore, do not discontinue Parapres Plus without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, Parapres Plus can cause adverse effects, although not everyone experiences them.

It is important that you are aware of the possible adverse effects. Some of the adverse effects of Parapres Plus are due to candesartan cilexetil, while 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 itching of the skin (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 periodically to ensure that Parapres Plus is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Frequent (affects 1 to 10 patients in every 100)

• Changes in blood test results:

• Reduction in blood sodium levels. If severe, you may feel weak, lack energy, or have muscle cramps.

• Increase or decrease in blood potassium levels, especially if you already have kidney problems or heart failure. If this condition is severe, you may experience tiredness, weakness, irregular heartbeat, or tingling sensations.

• Increase in blood cholesterol, glucose, or uric acid levels.

• Presence of glucose in urine.

• Dizziness or weakness.

• Headache.

• Respiratory infection.

Uncommon (affects less than 1 in every 100 patients)

• Low blood pressure. This may cause dizziness or fainting.
• Loss of appetite, diarrhea, constipation, stomach irritation.

Rare (affects less than 1 in every 1,000 patients)

• Jaundice (yellowing of the skin and whites of the eyes). If this occurs, contact your doctor immediately.
• Effects on kidney function, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression, or restlessness.
• Tingling or pins and needles in arms and legs.
• Blurred vision for a short period.
• Abnormal heartbeat.
• Breathing difficulties (including lung inflammation and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels causing 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 bruise easily.
• Severe skin reaction developing rapidly, causing blisters and skin peeling, and possibly mouth ulcers.
• Worsening of pre-existing lupus-like reactions or appearance of uncommon skin reactions.

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

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

Not known (frequency cannot be estimated from available data)

• Sudden onset of myopia.
• 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).
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Parapres Plus

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Parapres Plus

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

Appearance of the product and contents of the container

Parapres Plus is presented as pale pink, oval, flat tablets, approximately 8.5 mm by 5.1 mm, biconvex, scored, and engraved with "16 / C" on both sides.

Parapres Plus 16 mg/12.5 mg tablets are available in single-dose perforated blisters in packs of 28 or 300 tablets.

Not all pack sizes may be marketed in every country.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almirall, S.A.

General Mitre nº 151

08022 - Barcelona (Spain)

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 medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: January 2025.

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/)