Tensikey Complex 20 mg/12.5 mg tablets

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

TENSIKEY COMPLEX 20 mg/12.5 mg tablets

Lisinopril/Hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet; 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 others, 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 they are adverse effects not listed in this leaflet.

Contents of the leaflet

1. What TENSIKEY COMPLEX 20 mg/12.5 mg tablets are and what they are used for
2. What you need to know before taking 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. How to store TENSIKEY COMPLEX 20 mg/12.5 mg tablets
6. Contents of the pack and other information

1. What TENSIKEY COMPLEX 20 mg/12.5 mg tablets are and what they are used for

TENSIKEY COMPLEX 20 mg/12.5 mg tablets is a medicine with antihypertensive effect (to lower blood pressure).

TENSIKEY COMPLEX 20 mg/12.5 mg tablets contains two active substances: lisinopril, an antihypertensive belonging to the family known as “Angiotensin Converting Enzyme Inhibitors (ACE inhibitors)”, and hydrochlorothiazide, a diuretic (a medicine that increases urine production) belonging to the thiazide family. Both compounds have complementary mechanisms of action and exert an additional antihypertensive effect.

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 medicine of the ACE inhibitor family or to other drugs derived from sulfonamides.
• If you have a history of angioedema (swelling of the face, limbs, lips, tongue, and throat) related to previous treatment with a medicine of the same therapeutic group (ACE inhibitors).
• If you have hereditary or idiopathic angioedema.
• If you have anuria (low urine production).
• If you have renal failure (impaired kidney function).
• If you are pregnant or breastfeeding.
• If you have diabetes or renal impairment and are being treated with an antihypertensive medicine 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 low blood pressure after the first or second dose or when the dose is increased, contact your doctor.

• If you have any of the following conditions or are in any of the situations listed below, you may require a dose adjustment to prevent an excessive and sudden drop in blood pressure:

  • if you have impaired renal or hepatic function (such as renal artery stenosis or progressive liver disease),
  • if you suffer from heart disease (such as ischemic heart disease, hypertrophic cardiomyopathy, cerebrovascular disease, or aortic stenosis),
  • if you are undergoing dialysis,
  • if you are taking diuretics (medicines to increase urine output),
  • if you have electrolyte deficiency, follow a low-salt diet, or have frequent vomiting or diarrhea.

• 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.

See also the information under the heading “Do not take TENSIKEY COMPLEX 20 mg/12.5 mg tablets”.

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

• Before undergoing anesthesia or surgery, you must inform your doctor or anesthetist that you are taking this medicine, as it may cause a sudden drop in blood pressure.

• Before undergoing tests for parathyroid function, inform your doctor if you are taking this medicine.

• If you experience swelling of the face, lips, mouth, tongue, and/or larynx, or difficulty breathing, stop treatment immediately and seek medical attention without delay.

• If you are to receive desensitization treatment for an allergy (e.g., insect sting).

• If you have systemic lupus erythematosus, as this medicine may reactivate or worsen symptoms.

• If you have insulin-dependent diabetes, treatment should be initiated with low doses and under medical supervision, and adjustment of antidiabetic medicines, including insulin, may be required. This is because this medicine may alter glucose tolerance.

• If you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to a week after taking TENSIKEY COMPLEX 20 mg/12.5 mg tablets. This may lead to 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 condition.

• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV radiation while taking TENSIKEY COMPLEX 20 mg/12.5 mg tablets.

Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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

Never take a medicine on your own initiative without medical advice, as some combinations should be avoided.

LISINOPRIL-HYDROCHLOROTHIAZIDE should not be administered simultaneously with:

• Tubocurarine, as thiazides, such as hydrochlorothiazide, may enhance its effects.
• Diuretics (medicines to increase urine output), as they may increase the drop in blood pressure.
• Potassium supplements, potassium-containing salt substitutes, or potassium-sparing drugs, as they may increase blood potassium levels above normal.
• Lithium (a medicine used to treat certain types of depression).
• Anesthetics, narcotics, hypnotics.
• Other antihypertensive medicines, 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 medicine used to treat arthritis or muscle pain).
• Oral antidiabetics or insulin, as their effects may be increased by lisinopril.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking this medicine.

This medicinal product is excreted in breast milk. In general, treatment should be discontinued or breastfeeding stopped.

Driving and use of machines

There are no studies on the effect of this medicinal product on the ability to drive. This medicinal product may occasionally cause dizziness, vertigo, and fatigue; therefore, take this into account when driving vehicles or operating machinery.

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

Athletes are advised that this medicinal product contains a component that may lead to a positive analytical finding in doping controls.

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

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you how long to take TENSIKEY COMPLEX 20 mg/12.5 mg tablets. Do not stop treatment prematurely, as this may cause disturbances in your blood pressure.

If you feel that 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 use.

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

The dose is 1 or 2 tablets daily, administered as a single dose.

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

Essential hypertension

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

In general, if the desired therapeutic effect cannot be achieved within a period of 2 to 4 weeks with this dosage regimen, the dose may be increased to 2 tablets once daily.

Patients with renal impairment

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

In patients with mild renal impairment (creatinine clearance >30 and <80 ml/min), TENSIKEY COMPLEX 20 mg/12.5 mg tablets may be used, but only after adjusting the dosage of each component separately.

Prior diuretic therapy

If you have previously received diuretic treatment, consult your doctor before taking TENSIKEY COMPLEX 20 mg/12.5 mg tablets.

Use in children

Treatment is not recommended in children.

Use in elderly

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

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

If you have taken more than the prescribed amount, contact your doctor or pharmacist immediately. The most common symptoms are dizziness, fatigue, and vertigo due to sudden or excessive drop in blood pressure (hypotension), dehydration, weakness, and reduced urine output due to renal failure. The patient should be hospitalized so that appropriate treatment can be administered.

In case of overdose or accidental ingestion, contact 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 missed doses.

4. Possible adverse effects

Like all medicines, TENSIKEY COMPLEX 20 mg/12.5 mg tablets can produce adverse effects, although not everyone experiences 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 include: headache, cough, fatigue, and hypotension, including orthostatic hypotension (related to posture).

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

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

• Frequency "not known": Skin and lip cancer (non-melanoma skin cancer).

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

Fever, vasculitis (vein 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 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, which should be taken into account when performing blood tests.

Stop taking TENSIKEY COMPLEX 20 mg/12.5 mg tablets and contact your doctor immediately if you experience any of the following:

• Difficulty breathing with or without swelling of the face, lips, tongue and/or throat.
• Swelling of the face, lips, tongue and/or throat that may cause difficulty swallowing.
• Swelling of the hands, feet or ankles.
• Severe skin burning sensation.

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 not listed in this leaflet. You can also report them directly through 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 TENSIKEY COMPLEX 20 mg/12.5 mg tablets

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicine containers at the SIGRE collection point (SIGRE symbol) at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment. Do not use TENSIKEY COMPLEX 20 mg/12.5 mg tablets after the expiry date stated on the packaging.

6. Contents of the pack and other information

Composition of TENSIKEY COMPLEX 20 mg/12.5 mg tablets

Active substances: each tablet contains 20 mg of lisinopril (INN) (anhydrous) and 12.5 mg of hydrochlorothiazide (INN).

Other components (excipients): mannitol (E-421), anhydrous calcium hydrogen phosphate, corn starch, pregelatinized corn starch and magnesium stearate.

Appearance of the product and contents of the pack

TENSIKEY COMPLEX 20 mg/12.5 mg tablets are presented as white, round, biconvex tablets with a score line, supplied in packs of 28 tablets.

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 most recent revision of this leaflet: September 2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/