Package Insert: Information for the Patient

TENSIKEY COMPLEX 20 mg/12.5 mg Tablets

Lisinopril/Hydrochlorothiazide

Read this entire 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.

1. What is TENSIKEY COMPLEX 20 mg/12.5 mg Tablets and what it is used for

2. What you need to know before starting to take TENSIKEY COMPLEX 20 mg/12.5 mg Tablets

3. How to take TENSIKEY COMPLEX 20 mg/12.5 mg Tablets

4. Possible adverse effects

5. Storage of TENSIKEY COMPLEX 20 mg/12.5 mg Tablets

6. Contents of the package and additional information

TENSIKEY COMPLEX 20 mg/12.5 mg tablets are an anti-hypertensive medication (to lower blood pressure).

TENSIKEY COMPLEX 20 mg/12.5 mg tablets contain two active ingredients: lisinopril, an anti-hypertensive that belongs to the family of "Angiotensin-Converting Enzyme Inhibitors (ACEIs)" and hydrochlorothiazide, a diuretic (urine-producing medication) that belongs to the family of thiazides. Both compounds have complementary mechanisms of action and exert an additional anti-hypertensive effect.

TENSIKEY COMPLEX 20 mg/12.5 mg tablets are indicated for the treatment of Essential Hypertension, in patients for whom combined therapy of lisinopril and hydrochlorothiazide is appropriate.

Do not take Tensikey Complex 20 mg/12.5 mg tablets:

• If you are allergic (hypersensitive) to lisinopril, hydrochlorothiazide, or any of the excipients.
• If you are allergic (hypersensitive) to any angiotensin-converting enzyme (ACE) inhibitor or other sulfonamide-derived medications.
• If you have a history of angioneurotic edema (inflammation or swelling of the face, extremities, lips, tongue, and throat) related to previous treatment with a medication in the same therapeutic group (ACE inhibitors).
• If you have hereditary or idiopathic angioedema.
• If you have anuria (low urine production).
• If you have renal insufficiency (kidney function failure).
• If you are pregnant or breastfeeding.
• If you have diabetes or renal insufficiency and are being treated with a blood pressure medication containing aliskiren.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Tensikey Complex 20 mg/12.5 mg tablets:

- After the first dose, as you may experience a significant drop in blood pressure. If you experience a drop in blood pressure after the first or second dose or when increasing the dose, consult your doctor.

- If you have any of the following conditions or situations, you need to adjust the dose to avoid excessive and sudden drops in blood pressure:

- If you have renal or hepatic function alterations (such as renal artery stenosis or progressive liver disease),

• If you have heart disease (such as ischemic cardiomyopathy, hypertrophic cardiomyopathy, cerebrovascular disease, or aortic stenosis),
• If you are undergoing dialysis,
• If you are taking diuretics (urine medications),
• If you have electrolyte deficiencies, if you are on a low-sodium diet, have frequent vomiting or diarrhea.

- 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 renal problems related to diabetes.

- Aliskiren

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

See also the information under the heading "Do not take Tensikey Complex 20 mg/12.5 mg tablets".

- Before taking this medication, inform your doctor if you have had a kidney transplant or require hemodialysis.

- Before being anesthetized or undergoing surgery, inform your doctor or anesthesiologist if you are taking this medication, as it may cause a sudden drop in blood pressure.

- Before undergoing parathyroid function tests, inform your doctor if you are taking this medication.

- If you experience swelling of the face, lips, mouth, tongue, and/or larynx, or difficulty breathing, discontinue treatment and seek immediate medical attention.

- If you are undergoing desensitization treatment due to an allergy (for example, insect bite).

- If you have systemic lupus erythematosus, as this medication may reactivate or worsen symptoms.

- If you have insulin-dependent diabetes, initiate treatment with low doses and under medical supervision, and may require adjustment of antidiabetic medications, including insulin. This is because this medication may alter glucose tolerance.

- If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which can occur within a few hours to a week after taking Tensikey Complex 20 mg/12.5 mg tablets. This can cause permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing this.

Use of other medications

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medication, including those purchased without a prescription.

This is because Tensikey Complex 20 mg/12.5 mg tablets may affect the way some medications work, and some medications may have an effect on Tensikey Complex 20 mg/12.5 mg tablets. Your doctor may need to modify your dose and/or take other precautions.

You should never take a medication on your own initiative without your doctor's recommendation, as some combinations should be avoided.

Tensikey Complex 20 mg/12.5 mg tablets should not be administered simultaneously with:

- Tubocurarine, as thiazides, such as hydrochlorothiazide, may increase its response.

• Diuretics (urine medications), as it may increase blood pressure drops.
• Potassium supplements, salt substitutes with potassium, or potassium-sparing medications, as they may increase potassium levels in the blood above normal values.
• Lithium (a medication used to treat certain types of depression)
• Anesthetics, narcotics, hypnotics.
• Other antihypertensive medications, as they may add to the effects on blood pressure.
• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Tensikey Complex 20 mg/12.5 mg tablets" and "Warnings and precautions").
• Indomethacin (a medication used to treat arthritis or muscle pain).
• Oral antidiabetic medications or insulin, as they may increase the effects of lisinopril.

Nonsteroidal anti-inflammatory drugs (NSAIDs), used to treat symptoms such as fever, pain, and inflammation.

Pregnancy and lactation

Consult your doctor or pharmacist before taking this medication.

This medication is excreted in breast milk. In general, treatment should be interrupted or breastfeeding discontinued.

Driving and operating machinery

No studies have been conducted on the effect of this medication on driving ability. This medication may occasionally cause dizziness, vertigo, and fatigue, so be aware of this when driving vehicles or operating machinery.

Important information about some components of Tensikey Complex 20 mg/12.5 mg tablets

Warning to athletes: This medication contains a component that may result in a positive analytical result for doping control.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of treatment with TENSIKEY COMPLEX 20 mg/12.5 mg tablets. Do not discontinue treatment beforehand, as you may experience alterations in your blood pressure.

If you estimate that the action of TENSIKEY COMPLEX 20 mg/12.5 mg tablets is too strong or weak, inform your doctor or pharmacist.

The tablets are for oral administration.

Swallow the tablets with a sufficient amount of liquid – a glass of water.

The dose is 1 or 2 tablets per day, administered in a single dose.

TENSIKEY COMPLEX 20 mg/12.5 mg tablets should be taken approximately at the same time every day.

Essential Hypertension

The usual dose is 1 tablet once a day, taken approximately at the same time every day.

Generally, if the desired therapeutic effect cannot be achieved within a period of 2 to 4 weeks with this dosage, the dose can be increased to 2 tablets once a day.

Patients with Renal Insufficiency

TENSIKEY COMPLEX 20 mg/12.5 mg tablets should not be used as initial treatment in any patient with renal insufficiency.

In patients with mild renal insufficiency (creatinine clearance of >30 and <80

Previous Treatment with Diuretics

If you have received previous treatment with diuretics, consult your doctor before taking TENSIKEY COMPLEX 20 mg/12.5 mg tablets

Use in Children

Do not recommend treatment in children.

Use in the Elderly

Consult your doctor if you have any kidney problems, as you may need a dose adjustment.

If you take more TENSIKEY COMPLEX 20 mg/12.5 mg tablets than you should:

If you have taken more than you should, consult your doctor or pharmacist immediately. The most frequent symptoms are: feeling of dizziness, fatigue, and vertigo, due to sudden or excessive decrease in blood pressure (hypotension), dehydration, weakness, and decreased urine production due to renal insufficiency. The patient should be hospitalized for administration of appropriate treatment.

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

If you forgot to take TENSIKEY COMPLEX 20 mg/12.5 mg tablets:

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

Like all medicines, TENSIKEY COMPLEX 20 mg/12.5 mg tablets can cause side effects, although not everyone will experience them.

The majority of side effects of TENSIKEY COMPLEX 20 mg/12.5 mg tablets are mild and temporary.

• The most frequent adverse reaction is dizziness.

• Other frequent adverse reactions are: headache, cough, fatigue, and hypotension, including orthostatic hypotension (related to posture).

• Less frequent adverse reactions are: diarrhea, nausea, vomiting, dry mouth, skin rash, gout, palpitations, chest discomfort, muscle cramps, and weakness, tingling sensation, fatigue, and impotence.

• Rare adverse reactions are: angioedema, characterized by swelling of the face, extremities, lips, tongue, glottis, and/or larynx.

Occasionally, a complex of symptoms may occur, including one or more of the following situations:

Fever, vasculitis (venous inflammation), myalgia (muscle pain), arthralgia/arthritis (joint pain/inflammation), a positive ANA test, skin rash, photosensitivity (sensitivity to light), blood abnormalities such as elevated erythrocyte sedimentation rate, eosinophilia, and leukocytosis, or other dermatological manifestations.

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].

Some laboratory parameters may be altered, and this should be taken into account when performing tests.

Stop taking TENSIKEY COMPLEX 20 mg/12.5 mg tablets and immediately contact your doctor in any of the following situations:

• If you experience difficulty breathing with or without facial inflammation, lips, tongue, and/or throat.
• If you experience facial inflammation, lips, tongue, and/or throat that may cause difficulty swallowing.
• If you experience inflammation of the hands, feet, or ankles.
• If severe skin itching appears.

Reporting of adverse effects

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

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

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging of unused medicines at your local pharmacy's designated collection point (symbol). If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.Do not use TENSIKEY COMPLEX 20 mg/12.5 mg tablets after the expiration date appearing on the box.

Composition of TENSIKEY COMPLEX 20 mg/12.5 mg tablets

The active principles: each tablet contains 20 mg of lisinopril (DCI) (anhydrous) and 12.5 mg of hydrochlorothiazide (DCI).

The other components (excipients) are: mannitol (E-421), anhydrous calcium hydrogen phosphate, cornstarch, pregelatinized cornstarch, and magnesium stearate.

Appearance of the product and content of the packaging

TENSIKEY COMPLEX 20 mg/12.5 mg tablets are presented in the form of tablets in packs of 28 units. The tablets are white, round, biconvex with a fracture line.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

PHARMINICIO, S.L.

Paseo de La Habana, 9-11

28036 MADRID

Responsible for manufacturing

Laboratorio GENERFARMA, S.L.

C/ Isaac Peral 6 – Parque tecnológico

46980 Paterna – Valencia

Last review date of this leaflet: August 2022.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/