Package Insert: Information for the User

Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others 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 package insert. See section 4.

Lisinopril/Hidroclorotiazida Qualigen 20/12,5 mg tablets contain two active ingredients: lisinopril and hidroclorotiazida. Each one reduces blood pressure through a different mechanism. Lisinopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. Lisinopril acts by dilating blood vessels, helping to reduce blood pressure to facilitate the heart's ability to pump blood throughout the body. Hidroclorotiazida is a diuretic that increases the amount of urine produced by the kidneys.

Lisinopril/Hidroclorotiazida Qualigen 20/12,5 mg tablets are indicated for the treatment of high blood pressure (hypertension).

Do not take Lisinopril/Hidroclorotiazida Qualigen 20/12,5 mg tablets:

• If you have any kidney problems;
• If you are allergic (hypersensitive) to diuretics of the type of hydrochlorothiazide, which are similar to sulfonamides (a type of antibiotic), to lisinopril or to any of the other components of this medication (listed in section 6).
• If you have previously received a medication from the same group as Lisinopril/Hidroclorotiazida Qualigen 20/12,5 mg tablets (ACE inhibitors) and have had allergic reactions, possibly with swelling of the hands, feet, or ankles, face, lips, tongue, and/or throat with difficulty swallowing or breathing, or if you or a family member has experienced this reaction for any other reason.
• These tablets are only for your exclusive use and you should not provide them to anyone else.
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.

Warnings and precautions

Be especially careful with Lisinopril/Hidroclorotiazida Qualigen 20/12,5 mg tablets:

Consult your doctor or pharmacist before starting to take Lisinopril/Hidroclorotiazida Qualigen 20/12,5 mg tablets if:

• You know you have a narrowing of the aortic valve (aortic stenosis), of the renal arteries (renal artery stenosis), or an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy).
• You have any other health problem, such as diarrhea or vomiting, gout, liver or kidney problems, are undergoing dialysis, or are following a low-sodium diet, are taking potassium supplements or salt substitutes containing potassium, or are to receive an allergy desensitization treatment (for example, an insect bite).
• You have diabetes, as diuretics (such as hydrochlorothiazide) may require a change in the dose of your antidiabetic medications, including insulin.
• You have ever had an allergic reaction, possibly with swelling of the hands, feet, and ankles, face, lips, tongue, and/or throat with difficulty breathing.
• The initial dose may cause a more pronounced decrease in blood pressure than what is normally achieved with continued treatment; you may feel this by the presence of dizziness or dizziness, in which case lying down will help, but if you are concerned, consult your doctor.
• In the event of hospital admission, inform the healthcare staff and, in particular, the anesthesiologist (if you are to undergo surgery) that you are taking Lisinopril/Hidroclorotiazida Qualigen 20/12,5 mg tablets. Similarly, you should inform your dentist if you are to be treated with an anesthetic for a dental procedure.
• If you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The treatment with hydrochlorothiazide, particularly its 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 exposure to the sun and UV rays while taking Lisinopril/Hidroclorotiazida Qualigen.
• If you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within a few hours to a week after taking Lisinopril/Hidroclorotiazida Qualigen.
• 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 shortness of breath or severe difficulty breathing after taking Lisinopril/Hidroclorotiazida Qualigen, seek medical attention immediately.

Consult your doctor or pharmacist before starting to take Lisinopril/Hidroclorotiazida Qualigen 20/12,5 mg tablets if you are taking any of the following medications 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

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

Children

Lisinopril/Hidroclorotiazida Qualigen 20/12,5 mg tablets should not be administered to children.

Other medications and Lisinopril/Hidroclorotiazida Qualigen:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications, even those purchased without a prescription; in particular, diuretics, other antihypertensive medications for your high blood pressure, indomethacin or other medications for treating arthritis or muscle pain, or lithium (for certain psychiatric disorders). See "Do not take Lisinopril/Hidroclorotiazida Qualigen 20/12,5 mg tablets" and "Warnings and precautions".

Your doctor may need to adjust your dose and/or take other precautions:

• If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Lisinopril/Hidroclorotiazida Qualigen 20/12,5 mg tablets" and "Warnings and precautions").

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Lisinopril/Hidroclorotiazida Qualigen 20/12,5 mg tablets are not recommended during pregnancy or breastfeeding. Inform your doctor if you are pregnant, breastfeeding, or wish to become pregnant.

The ACE inhibitors (which include this product) may cause fetal damage and death when administered during the second and third trimesters of pregnancy.

If you detect that you are pregnant, you should discontinue this medication as soon as possible.

Driving and operating machinery:

It is unlikely that this medication will affect your ability to drive vehicles or operate machinery; however, you should not perform these activities that require special attention until you know how you tolerate this medication.

Important information about some of the components of Lisinopril/Hidroclorotiazida Qualigen 20/12,5 mg tablets:

It is reported to athletes that this medication contains a component that may result in a positive analytical result for doping control.

Follow exactly the administration instructions for this medication as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with Lisinopril/Hidroclorotiazida Qualigen 20/12.5 mg tablets. Do not stop treatment before your doctor tells you to.

Normal dose for adults:

The normal dose is one or two tablets per day.

The tablets are taken once a day.

Swallow the tablet with the help of water.

Try to take your tablets at the same time every day.

If you take more Lisinopril/Hidroclorotiazida Qualigen 20/12.5 mg tablets than you should:

If you ingest a dose higher than the normal dose, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Lisinopril/Hidroclorotiazida Qualigen 20/12.5 mg tablets:

Do not take a double dose to compensate for the missed doses and wait for the next administration.

If you interrupt treatment with Lisinopril/Hidroclorotiazida Qualigen 20/12.5 mg tablets:

Do not stop treatment before your doctor tells you to.

Do not stop taking your tablets if you feel well, unless your doctor tells you to.

If you have any other questions about this medication, ask your doctor or pharmacist.

Like all medicines, Lisinopril/Hidroclorotiazida Qualigen 20/12.5 mg tablets may cause side effects, although not everyone will experience them.

Lisinopril/Hidroclorotiazida Qualigen 20/12.5 mg tablets is generally well tolerated.

• The most frequent side effect (in a percentage between 1% and 10%; between 1 in 10 or 1 in 100 patients) that may occur is dizziness.
• Other side effects (in a percentage between 0.1% and 1%; between 1 in 100 and 1 in 1,000 patients) are: dizziness or lightheadedness (when standing up quickly), headache, diarrhea, nausea, skin rashes, psoriasis, cough, fatigue, weakness, numbness or "tingling" in the fingers or toes, changes in the taste of things, feeling of numbness or difficulty sleeping, strange dreams, nasal discharge or breast pain, vomiting, and vertigo.
• The rare side effects (in a percentage between 0.01% and 0.1%; between 1 in 1,000 and 1 in 10,000 patients) are: jaundice (yellow skin and/or eyes), no urine production or production of less urine or severe abdominal pain or indigestion.
• Other side effects (very rare, in a percentage less than 0.01%; less than 1 in 10,000 patients) that may occur are:

- Changes in some of the blood cells or other blood constituents; therefore, it is possible that your doctor may occasionally take blood samples to check if Lisinopril/Hidroclorotiazida Qualigen 20/12.5 mg tablets has caused any effect on it. Sometimes, these changes may manifest as fatigue or sore throat.

- Acute respiratory difficulty (the signs include severe respiratory difficulty, fever, weakness, and confusion).

• Unknown frequency: skin and lip cancer (non-melanoma skin cancer) and 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].

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this leaflet, consult your doctor or pharmacist.

Stop taking Lisinopril/Hidroclorotiazida Qualigen 20/12.5 mg tablets and contact your doctor immediately in any of the following situations:

• If you experience difficulty breathing with or without facial, lip, tongue, and/or throat inflammation.
• If you experience facial, lip, tongue, and/or throat inflammation, which may cause difficulty swallowing.
• If severe skin itching (with blisters) appears.

Do not be alarmed by this list of adverse reactions, as you may not experience any of them.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not appearing in this leaflet. You can also report them directly through the Spanish System of 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 medicine.

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

No special storage conditions are required.

Do not use Lisinopril/Hidroclorotiazida Qualigen 20/12.5 mg tablets after the expiration date shown on the packaging. 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 the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Lisinopril/Hidroclorotiazida Qualigen 20/12.5 mg tablets

• The active principles are lisinopril dihydrate (20 mg) and hydrochlorothiazide (12.5 mg).
• The other components are: calcium dihydrogen phosphate dihydrate, mannitol, cornstarch, pregelatinized starch, magnesium stearate, and iron oxide red (E-172).

Appearance of the product and content of the container

Lisinopril/Hidroclorotiazida Qualigen 20/12.5 mg is presented in the form of pink tablets, a calendar pack containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet: September 2022

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