IMPORTANT INFORMATION

Safety information

Carefully read the entire leaflet before starting the medication. Retain the leaflet for future reference. If in doubt, consult your doctor or pharmacist. This medication is prescribed specifically for you; do not share it with others, as it may be harmful even if they have similar symptoms. Keep Tensikey Complex away from children's reach and sight. No special storage conditions are required. Do not use after the expiration date indicated on the packaging. 

Before using TENSIKEY COMPLEX, do not take it if:

• You are allergic to lisinopril, hydrochlorothiazide, or any of its components.
• You are allergic to any ACE group hypertensive drug or other sulphonamide-derived drugs.
• You have a history of angio-neurotic edema (inflammation of face, limbs, lips, tongue, and throat) related to a prior ACE group medication.
• You have inherited or idiopathic angio-oedema.
• You have anuria (low urine production).
• You have renal insufficiency (impaired kidney function).
• You are pregnant or breastfeeding.

Exercise special care with TENSIKEY COMPLEX: After the initial dose, watch for potential strong hypotension. Consult your doctor if hypotension occurs after the first or second dose or after a dosage increase. If you have the following conditions, a dose adjustment is necessary to prevent excessive and sudden blood pressure drops: Renal or liver function alterations (e.g., renal arterial stenosis, progressive liver disease), Cardiac diseases (e.g., ischemic cardiopathy, hypertrophic cardiomyopathy, brain-vascular disease, aortic stenosis), Undergoing dialysis,Taking diuretics, experiencing electrolyte deficits, following a salt-restricted diet, vomiting, or having frequent diarrhea.

• Before taking the medicine, inform your doctor if you've had a renal transplant or require hemodialysis.
• Before anesthesia or surgery, inform your doctor or anesthetist about taking this drug to prevent sudden blood pressure drops.
• Before parathyroid function tests, inform your doctor if you are taking this drug.
• If you experience inflammation of the face, lips, mouth, tongue, and/or larynx or breathing difficulties, stop the treatment and inform your doctor promptly.
• If undergoing desensitization treatment for allergies.
• If you have systemic erythematosus lupus, as the drug may reactivate or worsen symptoms.
• If you have insulin-dependent diabetes, start treatment with low doses and under medical supervision. Adjustments to anti-diabetic drugs, including insulin, may be necessary. Consult your doctor, even if you've experienced any of the mentioned circumstances.

Pregnancy and lactation:

• Consult your doctor before taking this drug. ACE inhibitors, like this product, can cause fetal damage and death when administered during the second and third trimesters of pregnancy. Discontinue the drug as soon as pregnancy is confirmed. Interruption of treatment is recommended during lactation.

Driving and machinery use:

• No research on the effect of this drug on driving capacity is available. Be cautious as it may cause dizziness, vertigo, and fatigue, affecting your ability to drive or operate machinery.

Important information about components:

• Athletes are warned that this medicine contains a component that may result in a positive doping control.

Use of other medicines: Inform your doctor or pharmacist about any other drugs you are taking. Avoid self-administration of drugs without your doctor's recommendation, as some combinations should be avoided. Do not simultaneously use LISINOPRIL HYDROCHLOROTHIAZIDE with:

• Tubocurarine, as thiazides like hydrochlorothiazide may increase its response.
• Diuretics, as it may lead to a drop in blood pressure.
• Potassium supplements, potassium-sparing drugs, or salt substitutes with potassium, as they may elevate blood potassium levels.
• Lithium (used for treating certain types of depression).
• Anaesthetics, narcotics, hypnotics.
• Other antihypertensive drugs, as they may amplify effects on blood pressure.
• Indomethacin (used for treating arthritis and muscular pain).
• Oral antidiabetics or insulin, as their effects may be heightened with lisinopril.
• Non-steroidal anti-inflammatory drugs used for fever, pain, and inflammation.

Indications

It contains two active ingredients: lisinopril, an anti-hypertensive which belongs to the group of those called angiotensin converting enzyme inhibitors (ACE) and hydrochlorothiazide, a diuretic (medicine to urinate) that belongs to the thiacides group. Both compounds present complementary mechanisms of action and they provoke an additional anti-hypertensive effect. It is indicated in the essential hypertension treatment, in patients in which lisinopril and hydrochlorothiazide combined therapy is appropriate.

Ingredients

Each tablet contains 20 mg of lisinopril (anhydrous) and 12.5 mg of hydrochlorothiazide as active ingredients. The rest of the components (excipients) are: mannitol, dibasic calcium phosphate, maize starch, pre-gelatinised starch and magnesium stearate.

Instructions

Adhere to these instructions unless provided with different guidance by your doctor. Ensure consistent intake of Tensikey Complex for the prescribed treatment duration and continue the treatment to prevent potential arterial pressure fluctuations. If you find Tensikey Complex too strong or weak, inform your doctor or pharmacist. Take 1 or maximum 2 tablets orally with a glass of water, once a day at the same time. For essential hypertension, begin with 1 tablet daily at a consistent time. If the desired effect is not achieved within 2-4 weeks, the dose may be increased to 2 tablets daily. Avoid using Tensikey Complex as an initial treatment in patients with renal insufficiency. For patients with mild renal insufficiency (creatinine clearance >30 and <80 ml/min), adjust each component's dosage before using Tensikey Complex. If you've previously used diuretics, consult your doctor before starting this medication. Children: This medication is not recommended for use in children. Elderly: Consult your doctor if you have kidney problems, as a dose adjustment may be necessary. If you've taken more Tensikey Complex than prescribed, contact your doctor or pharmacist immediately. Common symptoms of overdose include dizziness, fatigue, vertigo, hypotension, dehydration, weakness, and decreased urine production due to renal insufficiency. Seek immediate medical attention; the patient may require hospitalization for appropriate treatment. In case of overdose or accidental ingestion, contact the Poison Centre. If you miss a dose of TENSIKEY COMPLEX, do not double the next dose to make up for the missed one. 

POSSIBLE ADVERSE EFFECTS: Like all medications, Tensikey Complex may cause adverse effects. Most side effects are mild and temporary, with dizziness being the most common. Other frequent reactions include headache, cough, fatigue, and hypotension, including orthostatic hypotension related to posture. Less common reactions include diarrhea, nausea, vomiting, dry mouth, skin rash, gout, palpitations, chest disturbances, muscle cramps and weakness, tingling sensation, fatigue, and impotence. Rarely, there may be angioedema, characterized by inflammation of the face, limbs, lips, tongue, glottis, and/or larynx. In some cases, a symptomatic complex may occur, involving fever, vasculitis, myalgia, arthralgia/arthritis, positive ANA test, skin rash, photosensitivity, and blood alterations such as high sedimentation rate, eosinophilia, and leukocytosis, or other dermatological signs. 

Discontinue Tensikey Complex and seek immediate medical attention if you encounter any of the following: difficulty breathing, swelling of the face, lips, tongue, and/or throat; difficulty swallowing due to facial swelling; swelling of hands, feet, or ankles; or severe skin irritation. Consult your doctor or pharmacist for any other reactions not mentioned in this leaflet.

How Supplied

TENSIKEY COMPLEX is presented in tablet form in packages of 28 units. The tablets are round and slotted and is a medicine with anti-hypertensive effect (to diminish arterial pressure).