Lisinopril + hydrochlorothiazide
Read all the leaflet carefully before beginning to take the medicine
• Keep out this leaflet. You may have to read it again.
• If you have any doubt, consult your doctor or chemist.
• This medicine has been prescribed you personally and you should not give it
to other people. It may be harmful for them, even if their symptoms are the same
In this leaflet:
1. What is TENSIKEY COMPLEX and what is it used for
2. Before taking TENSIKEY COMPLEX
3. How to take TENSIKEY COMPLEX
4. Possible adverse effects
5. TENSIKEY COMPLEX preservation
TENSIKEY COMPLEX 20/12.5 mg tablets
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.
Marketing Authorisation Holder and manufacturer
C/ Aribau 168-170
08036 Barcelona (Spain)
1. WHAT IS TENSIKEY COMPLEX AND WHAT IS IT USED FOR
TENSIKEY COMPLEX is presented in tablet form in packages of 28 units. The tablets are round and slotted.
TENSIKEY COMPLEX is a medicine with anti-hypertensive effect (to diminish arterial pressure).
TENSIKEY COMPLEX 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.
TENSIKEY COMPLEX is indicated in the essential hypertension treatment, in patients in which lisinopril and hydrochlorothiazide combined therapy is appropriate.
2. BEFORE TAKING TENSIKEY COMPLEX
Do not take TENSIKEY COMPLEX if:
• You have allergy (hypersensitivity) to lisinopril, hydrochlorothiazide, or to any of its excipients.
• You have allergy (hypersensitivity) to any hypertensive drug of the ACE group or other drugs derived from sulphonamide.
• You have angio-neurotic oedema precedents (inflammation of face, limbs, lips, tongue and throat) in relation to a previous treatment with a medicine of the same therapeutical group (ACE).
• You suffer from inherited or idiopathic angio-oedema.
• You suffer from anuria (low urine production).
• You suffer from renal insufficiency (impaired renal function).
• You are pregnant or in lactation time.
Be especially careful with TENSIKEY COMPLEX:
• After the first dose, as you can suffer a strong hypotension. If you experience hypotension after the first or second dose or after increasing the dose, consult your doctor.
• If you suffer from any of the following diseases or present any of the next situations, you need a dose adjustment to prevent from excessive and sudden fall of tension.
o If you have alterations in renal or liver function (such as renal arterial sthenosis (narrowing) or progressive liver disease),
o If you suffer from any cardiac disease (such as isquemic cardiopathy, hypertrophic myocardiopathy, brain-vascular disease, aortic sthenosis),
o If you are subjected to dialysis,
o If you are taking diuretics (medicines to urinate),
o If you have electrolytes deficit, if you follow a diet with salt restriction, vomits or frequent diarrhoea,
• Before taking this medicine, inform your doctor if you have experienced a renal transplant or if you require hemodialysis.
• Before being anaesthetised or subjected to surgery, you should inform your doctor or anaesthetiser if you are taking this drug, as a sudden fall of tension could happen.
• Before being subjected to parathyroid function tests, you should inform your doctor if you are taking this drug.
• If you experience inflammation of face, lips, mouth, tongue and/or larynx, or breathing difficulties, the treatment should be stopped and your doctor informed the soonest possible.
• If you are going to follow a desensitisation treatment because of an allergia (for instance, insect itching).
• If you suffer from systemic erythematous Lupus, as this drug may reactivate it or make the symptoms worse.
• If you suffer from insulin-dependent diabetes, you should begin the treatment with low doses and under medical supervision. A dose adjustment of anti-diabetic drugs can be required, including insulin. This can occur because this medicine may alter tolerance to glucose. Consult your doctor, even if any of the previously mentioned circumstances had ever happened to you.
Pregnancy and lactation
Consult your doctor or chemist before taking this drug.
The angiotensin converting enzyme inhibitors (group which this product belongs to) can cause damage and foetal death, when administered during the second and third quarter of pregnancy.
In case of pregnancy, the administration of this drug should be stopped as soon as possible.
This medicine is excreted in human milk. In general, treatment or lactation should be interrupted.
Driving and use of machinery
There are no researches of the effect of this drug on driving capacity. This medicine can occasionally cause dizziness, vertigo and fatigue, so take this into account when driving vehicles or using machines.
Important report about some of the components of TENSIKEY COMPLEX
Sportsmen are warned that this medicine contains a component that can set an analytic result of doping control as positive.
Use of other medicines
Inform your doctor or chemist if you are taking or have recently taken any other drug, even those acquired under no prescription.
You should never take a drug on your own without your doctor recommendation, since some combinations should be avoided. LISINOPRIL HYDROCHLOROTIACIDE should not be simultaneously administered with:
• Tubocurarine, since thiacides, such as hydrochlorothiazide, may increase its response.
• Diuretics (medicines to urinate), as fall of tension may rise.
• Potassium supplements, salt substitutes with potassium or potassium saving drugs, as they may raise potassium levels in blood over normal values.
• Lithium (drugs used for treating certain kind of depressions).
• Anaesthetics, narcotics, hypnotics.
• Other anti-hypertensive drugs, as effects on arterial pressure may increase.
• Indometacine (drug used for treating arthritis and muscular pain).
• Oral anti-diabetics or insuline, as their effects can be risen with lisinopril.
• Non-steroidal anti-inflammatory, used for treating symptoms such as fever, pain and inflammation.
3. HOW TO TAKE TENSIKEY COMPLEX
Follow these instructions unless your doctor has given you others.
Remember to take your medicine.
Your doctor will indicate you the treatment duration with TENSIKEY COMPLEX.
Do not stop the treatment before as you may suffer from arterial pressure alterations.
If you consider TENSIKEY COMPLEX action is too strong or too weak, let it know to your doctor or chemist.
The tablets are administered orally.
Take the tablets with enough amount of liquid – a glass of water.
The dose is 1 or 2 tablets once a day, administered in a single taking.
TENSIKEY COMPLEX should be taken approximately at the same time every day.
The usual dose is 1 tablet once a day, taken approximately at the same time every day.
In general, if the desired therapeutic effect cannot be achieved in a period of 2 or 4 weeks with this dosage, the dose can be raised to 2 tablets once a day.
Patients with renal insufficiency
TENSIKEY COMPLEX should not be used as an initial treatment in any patient with renal insufficiency.
In patients with mild renal insufficiency (creatinine lightening of >30 and <80 ml/min), TENSIKEY COMPLEX can only be used after adjusting the dosage of every component separately.
Previous treatment with diuretics
If you have followed a previous treatment with diuretics, consult your doctor before taking TENSIKEY COMPLEX.
Use in children
The treatment in children is not recommended.
Use in elderly people
Consult your doctor if you have any kidney problem, as you might need a dose adjustment.
If you take more TENSIKEY COMPLEX than you should:
If you have taken more than you should, consult your doctor or chemist immediately. The most frequent symptoms are: dizziness sensation, fatigue and vertigo, owing to the sudden or excessive fall of arterial tension (hypotension), dehydration, weakness and decrease of urine production because of renal insufficiency. The patient should be hospitalised to be administered the adequate treatment.
In the event of overdose or accidental ingestion, consult the Poison Centre.
If you forgot to take TENSIKEY COMPLEX
Do not take a double dose to compensate the forgotten doses.
4. POSSIBLE ADVERSE EFFECTS
As all the drugs, TENSIKEY COMPLEX can have adverse effects.
Most of the side effects of TENSIKEY COMPLEX are mild and transitory.
• The most frequent adverse reaction is dizziness.
• Other frequent adverse reactions are: headache, cough, fatigue and hypotension, including orthostatic hypotension (connected with posture).
• The adverse reactions of minor frequency are: diarrhoea, nausea, vomits, mouth dryness, cutaneous eruption, gout, palpitations, pectoral perturbances, muscular cramp and weakness, tingling sensation, tiredness and impotence.
• The adverse reactions of rare frequency are: angio-oedema, characterised by inflammation of face, limbs, lips, tongue, glottis and/or larynx.
Occasionally, a symptomatic complex can be given including one or more of the following situations:
Fever, vasculitis (venous inflammation), myalgia (muscular origin pain), arthralgia/arthritis (pain/joint inflammation), a positive ANA test, cutaneous eruption, photosensitivity (sensitivity to light), blood alterations such as high globular sedimentation, eosinophilia and leukocythosis or other dermatological signals.
Stop taking TENSIKEY COMPLEX and contact your doctor immediately in any of the following situations:
• If you experience breathing difficulty with or without inflammation of face, lips, tongue and/or throat.
• If you experience inflammation of face, lips, tongue and/or throat what can cause you difficulty to swallow.
• If you experience inflammation of hands, feet or ankles.
• In case of serious skin stinging.
If any other reaction non described in this leaflet occurs, consult your doctor or chemist.
5. TENSIKEY COMPLEX preservation
Keep TENSIKEY COMPLEX out of children’s reach and sight.
Special preserving conditions are not necessary.
Do not use TENSIKEY COMPLEX after the expiry date stated in the packaging.
This leaflet was approved in June 2001