TENSIKEY COMPLEX 20 mg/12.5 mg TABLETS

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

2. What you need to know before taking TENSIKEY COMPLEX 20 mg/12.5 mg tablets

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 antihypertensive medication from the ACEI family or other sulfonamide-derived medications.
• If you have a history of angioedema (inflammation or swelling of the face, extremities, lips, tongue, and throat) related to previous treatment with a medication from the same therapeutic group (ACEI).
• If you have hereditary or idiopathic angioedema.
• If you have anuria (low urine production).
• If you have renal insufficiency (kidney 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 diseases or situations, you may need a dose adjustment to avoid an excessive and sudden drop in blood pressure:

• if you have renal or hepatic function alterations (such as arterial 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 (medications to increase urine production),
• if you have electrolyte deficits, if you follow a low-salt 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" - e.g., valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems.
• aliskiren

Your doctor may 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 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 a sudden drop in blood pressure may occur.
• 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 consult your doctor immediately.
• If you are going to receive desensitization treatment due to an allergy (e.g., insect sting).
• If you have Systemic Lupus Erythematosus, as this medication may reactivate or worsen symptoms.
• If you have insulin-dependent diabetes, treatment should be started with low doses and under medical supervision, and the dose of antidiabetic medications, including insulin, may need to be adjusted. This is because this medication can alter glucose tolerance.
• If you experience a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and 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 left untreated. If you have previously been allergic to penicillin or sulfonamides, you may be at higher risk of developing this condition.

Use of other medications

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

This is because TENSIKEY COMPLEX 20 mg/12.5 mg tablets may affect how some medications work, and some medications may have an effect on TENSIKEY COMPLEX 20 mg/12.5 mg tablets. Your doctor may need to adjust your dose and/or take other precautions.

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 (medications to increase urine production), as this may increase the drop in blood pressure.
• Potassium supplements, potassium-containing salt substitutes, or potassium-sparing medications, as these may increase blood potassium levels above normal values.
• Lithium (a medication used to treat certain types of depression)
• Anesthetics, narcotics, hypnotics.
• Other antihypertensive medications, as their effects on blood pressure may be additive.
• 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 antidiabetics or insulin, as their effects may be increased with lisinopril.

Non-steroidal anti-inflammatory medications (NSAIDs), used to treat symptoms such as fever, pain, and inflammation.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking this medication.

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

Driving and using machines

There are no studies on the effect of this medication on driving ability. This medication may occasionally cause dizziness, vertigo, and fatigue, so take this into account when driving vehicles or operating machines.

Important information about some of the components of TENSIKEY COMPLEX 20 mg/12.5 mg tablets

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

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

Follow your doctor's instructions for taking this medication exactly. If in 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 without consulting your doctor, as you may experience changes in your blood pressure.

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

The tablets are for oral administration.

Take the tablets with a sufficient amount of liquid - a glass of water.

The dose is 1 or 2 tablets per day, taken 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.

In general, if the desired therapeutic effect is not achieved within 2 to 4 weeks with this dosage, the dose may 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 >30 and <80 ml min), tensikey complex 20 mg 12.5 tablets may be used, but only after adjusting the dosage of each component separately.< p>

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

Treatment is not recommended in children.

Use in the elderly

Consult your doctor if you have 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 common symptoms are: dizziness, fatigue, and vertigo, due to a sudden or excessive drop in blood pressure (hypotension), dehydration, weakness, and decreased urine production due to renal insufficiency. The patient should be hospitalized to receive appropriate treatment.

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

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

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

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

Most side effects of TENSIKEY COMPLEX 20 mg/12.5 mg tablets are mild and transient.

• The most common adverse reaction is dizziness.

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

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

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

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

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

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].

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

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

• 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 that may cause difficulty swallowing.
• If you experience swelling of the hands, feet, or ankles.
• If you experience severe itching of the skin.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging of medications you no longer need in the sigre (symbol sigre) collection point at your usual 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.Do not use TENSIKEY COMPLEX 20 mg/12.5 mg tablets after the expiration date stated on the carton.

6. Package contents and additional information

Composition of TENSIKEY COMPLEX 20 mg/12.5 mg tablets

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

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

Appearance of the product and package contents

TENSIKEY COMPLEX 20 mg/12.5 mg tablets are presented in the form of tablets in packages of 28 units. The tablets are white, round, biconvex, and have a score line.

Marketing authorization holder and manufacturer

Marketing authorization holder

PHARMINICIO, S.L.

C/ Aribau, 168-170

08036 Barcelona

Spain

Manufacturer

Laboratorio GENERFARMA, S.L.

C/ Isaac Peral 6 – Parque tecnológico

46980 Paterna – Valencia

Date of the last revision of this leaflet: August 2022.

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