LISINOPRIL/HYDROCHLOROTHIAZIDE QUALIGEN 20/12.5 mg TABLETS

2. What you need to know before taking Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets

Do not take Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets:

• If you have kidney problems;
• If you are allergic (hypersensitive) to diuretics of the hydrochlorothiazide type, 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 any medication from the same group as Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets (ACE inhibitors) and have presented 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 for your exclusive use only, and you should not provide them to anyone else.
• If you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.

Warnings and Precautions

Be particularly careful with Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets:

Consult your doctor or pharmacist before starting to take Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets if:

• You know you have a narrowing of the aortic valve (aortic stenosis), renal arteries (renal artery stenosis), or an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy).
• You have any other health problems, such as diarrhea or vomiting, gout, liver or kidney problems, are undergoing dialysis, or are on a low-salt diet, are taking potassium supplements or salt substitutes containing potassium, or are about to receive desensitization treatment for an allergy (e.g., insect sting).
• You have diabetes, as thiazide 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 inflammation 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 due to the presence of fainting or dizziness, in which case lying down will help, however, if you are concerned, consult your doctor.
• In case of hospitalization, inform the healthcare staff and, in particular, the anesthesiologist (if you are going to undergo surgery) that you are taking Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets. Similarly, you should inform your dentist if you are going to be treated with an anesthetic for a dental procedure.
• 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 and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Lisinopril/Hydrochlorothiazide Qualigen.
• If you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and can occur within a few hours to a week after taking Lisinopril/Hydrochlorothiazide 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 severe shortness of breath or difficulty breathing after taking Lisinopril/Hydrochlorothiazide Qualigen, seek medical attention immediately.

Consult your doctor or pharmacist before starting to take Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets if you are taking any of the following medications used to treat high blood pressure:

• An angiotensin II receptor antagonist (ARA) (also known as "sartans" - e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• Aliskiren

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

Children

Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets should not be administered to children.

Other Medications and Lisinopril/Hydrochlorothiazide Qualigen:

Inform your doctor or pharmacist if you are using, have recently used, or may need to use other medications, including those purchased without a prescription; in particular, diuretics, other antihypertensives for your high blood pressure, indomethacin or other medications for arthritis or muscle pain, or lithium (for certain psychiatric disorders). See "Do not take Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets" and "Warnings and Precautions".

Your doctor may need to modify 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/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets" and "Warnings and Precautions").

Pregnancy and Breastfeeding:

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

The administration of Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets is not recommended during pregnancy or breastfeeding. Inform your doctor if you are pregnant, breastfeeding, or plan to become pregnant.

Angiotensin-converting enzyme inhibitors (the group to which this product belongs) can cause fetal harm and death when administered during the second and third trimesters of pregnancy.

If you become pregnant, you should stop taking this medication as soon as possible.

Driving and Using Machines:

It is unlikely that this medication will affect your ability to drive 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 Components of Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets:

Athletes are informed that this medication contains a component that may result in a positive doping test.

3. How to Take Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets

Follow your doctor's instructions for taking this medication exactly.

Consult your doctor or pharmacist if you have doubts.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Lisinopril/Hydrochlorothiazide 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.

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/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets than you should:

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

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

If you forget to take Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets:

Do not take a double dose to make up for forgotten doses, and wait for the next administration.

If you interrupt treatment with Lisinopril/Hydrochlorothiazide 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 indicates otherwise.

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

4. Possible Side Effects

Like all medications, Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets can have side effects, although not everyone experiences them.

Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets is generally well tolerated.

• The most frequentside effect (in a percentage between 1% and 10%; between 1 in 10 or 1 in 100 patients) that may occur is dizziness.
• Other uncommonside 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 of the hands or feet, changes in taste, feeling of numbness or difficulty sleeping, strange dreams, runny nose or sinus pain, vomiting, and vertigo.
• Rareside 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 decreased production or severe abdominal pain or indigestion.
• Other very rareside effects (in a percentage less than 0.01%; less than 1 in 10,000 patients) that may occur are:

• changes in some blood cells or other blood components; therefore, your doctor may occasionally take blood samples to check if Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets has caused any effect on the blood. Sometimes, these changes can manifest as fatigue or sore throat.
• acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).

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

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

Stop taking Lisinopril/Hydrochlorothiazide 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 inflammation of the face, lips, tongue, and/or throat.
• If you experience inflammation of the face, lips, tongue, and/or throat, which can cause difficulty swallowing.
• If you experience severe itching of the skin (with hives).

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

Reporting Side Effects

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

5. Storage of Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg Tablets

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

Appearance of the Product and Package Contents

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the Last Revision of this Package Leaflet: September 2022

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