Prospect: information for the user

Parapres Plus Forte 32 mg/25 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 notbe givento 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 ParapresPlus Forte and what is it used for

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

3.How to take Parapres Plus Forte

4.Possible adverse effects

5.Storage of Parapres Plus Forte

6.Contents of the package and additional information

Your medication is called Parapres Plus Forte. 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 your 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's elimination of water and salt, such as sodium, in urine. This facilitates a decrease in blood pressure.

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

Do not take Parapres Plus Forte

• 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 Forte during the first months of pregnancy – see Pregnancy section).
• if you have severe kidney disease.
• if you have severe liver disease or bile duct obstruction (problem with the bile flowing out of 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 failure 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 Forte.

Warnings and precautions

Consult your doctor before starting to take Parapres Plus Forte,

• if you are diabetic.
• if you have heart, liver or kidney problems.
• if you have recently had a kidney transplant.
• if you have frequent vomiting or have had diarrhea recently.
• 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:
• • a type of ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from the sun and UV rays while taking Parapres Plus Forte.
• if you experience a decrease in vision or eye pain. This could be a sign of fluid accumulation in the eye's vascular layer (choroidal effusion) or increased eye pressure, which can occur within a few hours to weeks after taking Parapres Plus Forte. This can lead to permanent vision loss if not treated. If you have previously had an allergy to sulfonamide or penicillin, you may be at 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 Forte, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting or diarrhea after taking Parapres Plus Forte. Your doctor will decide whether to continue treatment. Do not stop taking Parapres Plus Forte 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 information in the section “Do not take Parapres Plus Forte”

Inform your doctor if you are pregnant (or if you suspect you may be).

Parapres Plus Forte 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 Forte. This is because Parapres Plus Forte, in combination with some anesthetics, may cause a drop in blood pressure.

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

Children

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

Other medicines and Parapres Plus Forte

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

Parapres Plus Forte may affect how some medicines work and some medicines may affect the effect of Parapres Plus Forte. 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 medicines, as 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).
• Acetylsalicylic acid (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 lower cholesterol, such as colestipol or colestiramine.
• 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).
• Glucocorticoids such as prednisolone.
• Pituitary hormone (ACTH).

• Cancer medicines.
• 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 mouth 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 Forte” and “Warnings and precautions”)

Taking Parapres Plus Forte with food, drinks and alcohol

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

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 Forte before becoming pregnant or as soon as you know you are pregnant, and will recommend taking another medicine instead of Parapres Plus Forte. Parapres Plus Forte 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 onwards, 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 Forte is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish 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 Forte. If this happens to you, do not drive or operate tools or machines.

Parapres Plus Forte contains lactose

Lactose is a type of sugar. If your doctor has told 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 produce a positive result in doping control tests.

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

It is essential to continue taking Parapres Plus Forte every day.

The recommended dose is one tablet once a 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 groove is only intended to help break the tablet if you have difficulty swallowing the entire tablet.

If you take more Parapres Plus Forte than you should

If you have taken more Parapres Plus Forte 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 Forte

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

If you interrupt treatment with Parapres Plus Forte

If you stop taking Parapres Plus Forte, your blood pressure may increase again. Therefore, do not stop taking Parapres Plus Forte 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 Forte 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 Forte are due to candesartan cilexetilo, and others are due to hydrochlorothiazide.

Stop taking Parapres Plus Forte 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 Forte 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 Forte 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 already 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.

Infrequent (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.

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 already 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 that causes symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• Swelling of the face, lips, tongue, and/or throat.
• Acute respiratory difficulty (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 high 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 Forte after the expiration date shown on the packaging or blister. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy.If in doubtask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Compositionof Parapres Plus Forte

• Parapres Plus Forte tablets contain the following active ingredients: candesartan cilexetil and hydrochlorothiazide. The tablets contain 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.
• The other components are: calcium carbonate, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, cornstarch, macrogol, and iron oxide red (E172).

Appearance of the product and contents of the packaging

Parapres Plus Forte 32 mg/25 mg tablets are presented in the form of pale pink, oval, flat, approximately 11 mm by 6.5 mm, scored tablets with the imprint 32 / C2 on both sides.

Parapres Plus Forte 32 mg/25 mg tablets are presented in a pre-cut single-dose blister pack in packs of 28 tablets.

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

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