Lisinopril/hydrochlorothiazide Qualigen 20/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets EFG

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

Contents of the leaflet:

1. What Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets are and what they are used for
2. What you need to know before taking Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets
3. How to take Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets
4. Possible side effects
5. How to store Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets
6. Contents of the pack and other information

1. What Lisinopril/Hydrochlorothiazide 20/12.5 mg Tablets Are and What They Are Used For

Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets contain two active substances: lisinopril and hydrochlorothiazide. Each of these reduces blood pressure through a different mechanism. Lisinopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. Lisinopril works by dilating blood vessels, helping to lower blood pressure and making it easier for the heart to pump blood throughout the body. Hydrochlorothiazide is a diuretic that increases the amount of urine produced by the kidneys.

Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets are indicated for the treatment of high blood pressure (hypertension).

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 any kidney problems;
• If you are allergic (hypersensitive) to diuretics of the hydrochlorothiazide type, which are drugs similar to sulfonamides (a type of antibiotic), to lisinopril, or to any of the other ingredients of this medicine (listed in section 6);
• If you previously took a medicine of the same class as Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets (ACE inhibitors) and experienced allergic reactions, possibly with swelling of the hands, feet or ankles, face, lips, tongue and/or throat, difficulty swallowing or breathing, or if you or a family member has experienced such a reaction for any other reason;
• These tablets are for your use only and must not be given to anyone else;
• If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Take special care with Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets:

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

• You know you have narrowing of the aortic valve (aortic stenosis), narrowing of the renal arteries (renal artery stenosis), or thickening 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, 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 adjustment of your antidiabetic medication, including insulin;
• You have ever had an allergic reaction, possibly with swelling of the hands, feet and ankles, face, lips, tongue and/or throat, or difficulty breathing;
• The initial dose may cause a more pronounced drop in blood pressure than normally seen during continued treatment; you may experience this as fainting or dizziness—in such cases, lying down may help; however, if you are concerned, consult your doctor;
• If you are admitted to hospital, inform healthcare staff, and especially the anaesthetist (if undergoing surgery), that you are taking Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets. Similarly, inform your dentist if you are to be treated with a dental anaesthetic;
• 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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Lisinopril/Hydrochlorothiazide Qualigen;
• 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 one week after taking Lisinopril/Hydrochlorothiazide Qualigen;
• If you have previously experienced respiratory or pulmonary problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Lisinopril/Hydrochlorothiazide Qualigen, seek medical attention immediately.

Consult your doctor or pharmacist before starting Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets 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.

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 must not be given to children.

Other medicines and Lisinopril/Hydrochlorothiazide Qualigen:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription; in particular, diuretics, other antihypertensives for high blood pressure, indomethacin or other drugs used to treat arthritis or muscle pain, or lithium (for certain psychiatric conditions). See “Do not take Lisinopril/Hydrochlorothiazide 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 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 medicine.

Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets are not recommended during pregnancy or breastfeeding. Inform your doctor if you are pregnant, breastfeeding, or intend to become pregnant or breastfeed.

ACE inhibitors (the class to which this product belongs) may cause fetal harm and death when administered during the second and third trimesters of pregnancy.

If you become pregnant, you must discontinue this medicine as soon as possible.

Driving and use of machines:

It is unlikely that this medicine will affect your ability to drive or operate machinery; however, you should not perform such activities requiring special attention until you know how you react to this medicine.

Important information about some of the components of Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets:

Athletes should be aware that this medicine contains a component that may result in a positive analytical finding in doping control tests.

3. How to take Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets

Follow exactly the instructions for use of this medicine provided by your doctor.

If you have any doubts, consult your doctor or pharmacist.

Remember to take your medicine.

Your doctor will tell you how long to take Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets. Do not stop treatment before your doctor tells you to do so.

Normal dose for adults:

The normal dose is one or two tablets every day.

The tablets are taken once daily.

Swallow the tablet with 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 higher dose than normal, contact your doctor or nearest hospital.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 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; wait until your next scheduled dose.

If you stop taking Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets:

Do not stop treatment before your doctor tells you to do so.

Do not stop taking your tablets if you feel well, unless your doctor instructs you otherwise.

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

4. Possible adverse effects

Like all medicines, Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets may have adverse effects, although not everyone experiences them.

Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets are generally well tolerated.

• The most common adverse effect (occurring in 1% to 10%; between 1 in 10 and 1 in 100 patients) is dizziness.

• Other uncommon adverse effects (occurring in 0.1% to 1%; between 1 in 100 and 1 in 1,000 patients) are: dizziness or lightheadedness (upon standing quickly), headache, diarrhea, nausea, skin rash, psoriasis, cough, fatigue, weakness, numbness or "pins and needles" sensation in fingers of hands or feet, changes in taste, tingling sensation or difficulty sleeping, strange dreams, runny nose or sinus pain, vomiting, and vertigo.

• Rare adverse effects (occurring in 0.01% to 0.1%; between 1 in 1,000 and 1 in 10,000 patients) are: jaundice (yellowing of the skin and/or eyes), lack of urine production or reduced urine output, or severe abdominal pain or indigestion.

• Other very rare adverse effects (occurring in less than 0.01%; fewer than 1 in 10,000 patients) that may occur are:

• changes in certain blood cells or other blood components; therefore, your doctor may occasionally take blood samples to check whether Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets have caused any effect on your blood. Sometimes, these changes may manifest as fatigue or sore throat.

• acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion).

• Frequency not known: 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 any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, consult your doctor or pharmacist.

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

• If you experience difficulty breathing with or without swelling of the face, lips, tongue, and/or throat.
• If you experience swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing.
• If you develop severe skin burning sensation (with hives).

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets

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

No special storage conditions are required.

Do not use Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg tablets after the expiry date stated on the packaging. 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 collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other 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, manitol, corn starch, pregelatinized starch, magnesium stearate and red iron oxide (E-172).

Appearance of the product and contents of the pack

Lisinopril/Hydrochlorothiazide Qualigen 20/12.5 mg is presented as pink tablets, in 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 most recent revision of this leaflet: September 2022

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