Prinivil Plus 20 mg/12.5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Prinivil Plus 20 mg / 12.5 mg tablets

lisinopril / 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 you should not give it to others, 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.

Leaflet contents:

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

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

The lisinopril component of Prinivil Plus is a medicine belonging to a group known as angiotensin-converting enzyme (ACE) inhibitors. The hydrochlorothiazide component of Prinivil Plus is a medicine belonging to a group known as diuretics.

The lisinopril component of Prinivil Plus dilates blood vessels, making it easier for the heart to pump blood to all parts of the body. The hydrochlorothiazide component of Prinivil Plus causes the kidneys to excrete more water and salt. Together, both components help reduce high blood pressure.

Lisinopril/hydrochlorothiazide is indicated for essential hypertension (high blood pressure).

2. What you need to know before taking Prinivil Plus

Do not take Prinivil Plus

• if you are allergic (hypersensitive) to lisinopril, hydrochlorothiazide, or any of the other components of this medicine (listed in section 6).

• if you are allergic (hypersensitive) to any sulfonamide-derived drug or to any other angiotensin-converting enzyme (ACE) inhibitor. If you are unsure which drugs these are, consult your doctor.

• if you have previously been treated with medicines from the same group as lisinopril (ACE inhibitors) and experienced allergic reactions such as swelling of the face, lips, tongue, and/or throat, with difficulty swallowing or breathing. You must not take lisinopril/hydrochlorothiazide if you have had such reactions of unknown cause or if you have been diagnosed with idiopathic or hereditary angioedema.

• if you are more than 3 months pregnant (this medicine should also be avoided in early pregnancy – see Pregnancy section).

• if you are not urinating.

• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, for example in the throat) is high.

• if you are taking any of the following medicines, the risk of developing angioedema may increase:

• Racecadotril, a medicine used to treat diarrhoea.

• Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).

• Vildagliptin, a medicine used to treat diabetes.

Consult your doctor if you are unsure whether you should start taking lisinopril/hydrochlorothiazide.

Warnings and precautions

Consult your doctor or pharmacist before starting Prinivil Plus:

• if you experience difficulty breathing or swallowing, with or without swelling of the face, lips, tongue, and/or throat, stop taking this medicine immediately and seek urgent medical attention. It should be noted that patients of black racial origin have an increased risk of these types of reactions to ACE inhibitors.

• if you are taking any of the following medicines, the risk of angioedema (rapid swelling beneath the skin, for example in the throat) increases:

• Temsirolimus, sirolimus, everolimus, and other medicines in the class of mTOR inhibitors (used to prevent rejection of transplanted organs).

• if you have recently experienced excessive vomiting or diarrhoea.

• if you have narrowing of the aorta (aortic stenosis), narrowing of the renal arteries (renal artery stenosis), narrowing of heart valves (mitral valve stenosis), or thickening of the heart muscle (hypertrophic cardiomyopathy).

• if you have impaired kidney function or are undergoing dialysis.

• if you have liver failure (impaired liver function).

• if you have a blood vessel disorder (collagen vascular disease) and/or are being treated with allopurinol (for gout), procainamide (for heart rhythm disorders), or immunosuppressants (medicines that suppress the body's immune response), as you may develop serious infections. In such cases, inform your doctor immediately if you notice any signs of infection.

• if you have diabetes and are taking oral antidiabetic medicines or insulin. Lisinopril/hydrochlorothiazide may increase the risk of hypoglycaemia (low blood sugar levels), so you should monitor your glucose levels more closely, especially during the first month of treatment with this medicine. A change in the dose of your diabetes medicines may be necessary.

• if you are on a salt-free diet, take potassium supplements or salt substitutes containing potassium, take potassium-sparing diuretics (medicines that increase urine output), have diabetes, or have any kidney problems, as these may cause significant increases in blood potassium levels. In such cases, your doctor may need to adjust the dose of Prinivil Plus or monitor your blood potassium levels.

• if you have a cough, as this may be related to treatment.

• if you have gout or high cholesterol levels.

• if you are about to undergo a treatment called low-density lipoprotein (LDL) apheresis.

• if you are about to undergo desensitisation treatment to reduce the effects of an allergy to bee or wasp stings.

• if you have had skin cancer or 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 non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Prinivil Plus.

• if you experience vision changes or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to a week after taking Prinivil Plus.

Inform your doctor if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• An angiotensin II receptor antagonist (ARA), also known as “sartans” – for example, valsartan, telmisartan, irbesartan – particularly if you have kidney problems related to diabetes.
• Aliskiren.
• If you are taking a medicine containing a neprilysin inhibitor (e.g., sacubitril or sacubitril/valsartan). Prinivil Plus must not be administered within 36 hours before or after taking sacubitril/valsartan.

Your doctor may need to monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Prinivil Plus”.

The use of lisinopril/hydrochlorothiazide, especially during the first doses, may cause a sudden drop in blood pressure (you may feel faint or dizzy upon standing). In such cases, lying down may help.

Before undergoing surgery with general or local anaesthesia (including at the dentist), inform the doctor or dentist that you are taking this medicine, as a sudden drop in blood pressure may occur in association with anaesthesia.

Inform your doctor if you think you are pregnant (or could be). Lisinopril/hydrochlorothiazide 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 your baby if used at this stage (see Pregnancy section).

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Children

Safety and efficacy have not been established in children.

Other medicines and Prinivil Plus

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

In particular, speak with your doctor or pharmacist if you are taking, have recently taken, or may need to take any of the following medicines:

• Diuretics (medicines that increase urine output).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (“water tablets”), and other medicines that may increase blood potassium levels (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to prevent blood clots).
• Medicines for mental disorders such as lithium, antipsychotics, or tricyclic antidepressants.
• Medicines for arthritis or muscle pain, such as gold salts and non-steroidal anti-inflammatory drugs (NSAIDs), including indomethacin and high-dose aspirin (more than 3 grams per day).
• Other antihypertensives (medicines that lower high blood pressure).
• If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Prinivil Plus” and “Take special care with Prinivil Plus”).
• Sympathomimetic medicines (which stimulate the central nervous system).
• Medicines for the treatment of diabetes, such as insulin or oral antidiabetics.
• Medicines more commonly used to prevent organ transplant rejection (temsirolimus, sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”.
• Medicines containing a neprilysin inhibitor (e.g., sacubitril).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Use of Prinivil Plus during pregnancy is not recommended.

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking Prinivil Plus before becoming pregnant or as soon as you know you are pregnant, and will switch you to another medicine. Prinivil Plus is not recommended during early pregnancy and must not be taken at all if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Prinivil Plus is not recommended for breastfeeding mothers, and if you wish to breastfeed, your doctor may choose an alternative treatment, especially if your baby is a newborn or was premature.

Driving and using machines

Individual responses to medication may vary. Certain adverse effects have been reported with lisinopril/hydrochlorothiazide that could affect the ability of some patients to drive or operate machinery. If you experience symptoms such as dizziness or fatigue, avoid tasks requiring special attention until you know how you tolerate the medicine (see section 4. Possible side effects).

Use in athletes

Athletes should be informed that this medicine contains a component (hydrochlorothiazide) that may result in a positive analytical finding in doping controls.

3. How to take Prinivil Plus

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Remember to take your medicine. Your doctor will decide the appropriate dose according to your condition and whether or not you are taking other medicines.

The recommended dose is one tablet once daily, taken orally, with or without food. Most people take this medicine with water.

If you feel that the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

Take this medicine daily, following your doctor's instructions exactly. It is very important to continue taking it for as long as your doctor recommends.

Do not take more tablets than the prescribed dose.

If you take more Prinivil Plus than you should

If you have taken more Prinivil Plus than you should, contact your doctor or pharmacist immediately.

The most likely symptoms will be dizziness or lightheadedness due to lowered blood pressure and/or excessive thirst, confusion, reduced urine volume, or rapid heartbeat.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Prinivil Plus

You should take this medicine as prescribed. Do not take a double dose to make up for missed doses. Continue with your prescribed dosing schedule.

If you stop taking Prinivil Plus

Do not stop taking this medicine even if you feel well, unless your doctor tells you to.

Your doctor will advise you on how long to take Prinivil Plus. Do not stop treatment earlier.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

If you experience any of the following effects, stop taking this medicine and seek immediate medical attention in any of the following cases:

• if you notice swelling of the face, lips, tongue and/or throat causing difficulty breathing or swallowing
• if you notice swelling of the hands, feet or ankles
• if you develop hives.

It should be noted that patients of black race have an increased risk of these types of reactions to ACE inhibitors.

The initial dose may cause a greater drop in blood pressure than occurs during continued treatment. Symptoms may include faintness and dizziness. In such cases, it is advisable to lie down. If you are concerned, consult your doctor.

The adverse effects observed are limited to those previously reported with lisinopril or hydrochlorothiazide.

Adverse effects of medicines are classified as follows:

Very common: may affect more than 1 in 10 people.

Common: may affect up to 1 in 10 people.

Uncommon: may affect up to 1 in 100 people.

Rare: may affect up to 1 in 1,000 people.

Very rare: may affect up to 1 in 10,000 people.

Frequency not known: frequency cannot be estimated from the available data.

Common (may affect up to 1 in 10 people)

• dizziness or lightheadedness, especially when standing up quickly
• diarrhoea
• vomiting
• cough
• dizziness
• headache.

Uncommon (may affect up to 1 in 100 people)

• rapid or irregular heartbeat
• tingling sensation in certain limbs
• skin rash
• nausea
• inability to achieve an erection (impotence)
• fatigue
• tiredness and feeling weak.

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

• dry mouth.

Very rare (may affect up to 1 in 10,000 people)

• inflammation of the pancreas.

Frequency not known (frequency cannot be estimated from the available data)

• muscle cramps or muscle weakness
• gout
• chest pain.

Additional adverse effects reported for the individual components that could be potential adverse effects of this medicine are:

HYDROCHLOROTHIAZIDE

Frequency not known (frequency cannot be estimated from the available data)

• decrease in the number of blood cells
• decrease in red blood cells due to their premature destruction
• low levels of white blood cells
• decrease in a certain type of white blood cells (neutrophils)
• decrease in the number of platelets
• low platelet count, sometimes with bleeding or bruising under the skin
• damage to blood vessels that may cause red or purple spots on the skin
• allergic reactions
• severe skin reaction developing rapidly, causing blisters and peeling of the skin, and possibly mouth ulcers
• kidney failure
• impaired kidney function
• inflammation of the kidney
• yellowing of the skin or whites of the eyes
• photosensitivity reactions
• skin rash
• respiratory disorders including pneumonia and fluid accumulation in the lungs
• inflammation of the salivary glands
• yellow vision
• transient blurred vision
• 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]
• imbalance of blood electrolytes (including low sodium levels)
• high levels of uric acid in the blood
• high levels of glucose in blood and/or urine
• loss of appetite
• stomach irritation
• constipation
• vertigo
• fever
• muscle spasms
• fatigue
• skin and lip cancer (non-melanoma skin cancer).

LISINOPRIL

Common (may affect up to 1 in 10 people)

• impaired kidney function.

Uncommon (may affect up to 1 in 100 people)

• myocardial infarction or stroke, possibly secondary to excessive drop in blood pressure in high-risk patients
• rapid or irregular heartbeat
• stomach pain
• itching of the skin
• mood disturbances.

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

• acute kidney failure
• increased levels of urea in the blood
• skin rash
• hair loss
• mental confusion.

Very rare (may affect up to 1 in 10,000 people)

• decreased ability of the body to produce blood cells, manifested as
• decreased number of red blood cells, platelets and/or white blood cells
• excessive release of antidiuretic hormone (leading to symptoms such as weakness, fatigue and confusion)
• inflammation of the liver
• yellowing of the skin and whites of the eyes
• pseudolymphoma of the skin
• difficulty breathing
• decreased urine output or inability to urinate
• increased sweating
• acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness and confusion).

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 through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Prinivil Plus

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Prinivil Plus

• The active substances are lisinopril (as dihydrate) and hydrochlorothiazide.

Each tablet contains 20 mg of lisinopril (as dihydrate) and 12.5 mg of hydrochlorothiazide.

• The other components are: mannitol (E-421), calcium hydrogen phosphate dihydrate, corn starch, pregelatinized corn starch, magnesium stearate, and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Yellow, hexagonal tablet, scored on one side. Prinivil Plus is available in packs of 28 tablets.

Prinivil Plus contains two different active substances.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

PAN QUÍMICA-FARMACÉUTICA, S.A.

Rufino González, 50

28037 Madrid

Spain

Manufacturer

ROVI Pharma Industrial Services, S.A.

Vía Complutense, 140

Alcalá de Henares 28805 – Madrid

(Spain)

Local Representative

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

Date of latest review of this leaflet: February 2022

Up-to-date and detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es