TENSIKEY 20 mg

(PHARMINISIO S.L. SPAIN)

Each tablet contains 5 mg of lisinopril as an active substance in form of lisinopril dihydrate. The other components (excipients) are mannitol, dibasic calcium phosphate, maize starch, pregelatinised starch, and magnesium stearate.

Marketing Authorisation Holder:

Pharminicio, S.L.
C/ Aribau 168-170.
08036 Barcelona
Spain

Manufacturer:
Generfarma S.L.
C/İsaac Peral 6, Parque Tecnológico,
46980 Paterna (Valencia)
Spain

1. WHAT TENSIKEY 20 mg tablets IS AND WHAT IT IS USED FOR.

TENSIKEY 20 mg is presented in form of round white grooved tablets. Each package contains 60 tablets.

TENSIKEY belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). ATC Code C09AA.

TENSIKEY is indicated for:
• Treatment of hypertension (high blood pressure).
• Treatment of symptomatic heart failure.
• Short-term treatment of acute myocardial infarction.
• Treatment of renal complications of type II diabetes in hypertensive patients.

2. BEFORE YOU TAKE TENSIKEY 20 mg tablets.

Do not take TENSIKEY if:
• You are allergic to lisinopril, to other medicines of the same group (ACE inhibitors), or to any component of this medicine.
• You have previously received a medicine of the same group as lisinopril (ACE inhibitors) and has had an allergic reaction that caused hand, foot, ankle, face, lip, tongue and/or throat swelling with difficulty to swallow or breath, or if you or a member of your family has had a similar reaction (angioedema).
• You are pregnant. (See section “Pregnancy and breast-feeding”).

Be especially careful with TENSIKEY:
• If you had coarctation of the aorta (aortic stenosis), of renal arteries (renal artery stenosis), or of the heart valves (mitral valve stenosis), or an increase in heart muscle thickness (hypertrophic myocardiopathy).
• If you suffer from acute myocardial infarction.
• If you had renal impairment or if you are on dialysis.
• If you suffer from hepatic failure.
• If you suffer from blood vessel disease (collagen vascular disease) and/or if you are under treatment with allopurinol (for gout disease), procainamide (for heart rate alterations), immunosuppressors (medicines that suppresses the immunological response of the body).
• If you have diabetes.
• If you follow a diet without salt, take potassium supplements, potassium-sparing diuretics or potassium substitutes containing potassium, or if you have recently suffered from excessive vomiting or diarrhoea.
• If you have cough.
• If you are going to follow a treatment called low-density lipoproteins aphaeresis, or a desensitisation treatment to reduce the effect of allergy to bee or wasp itching.
• If you have low blood pressure (you can notice this in form of faints or dizziness, especially in initial doses and when standing up. In these cases, lying down might help you.)

In all these cases, inform your doctor, as you may need a dose adjustment or stopping medication with TENSIKEY.

Stop taking TENSIKEY and immediately call for medical assistance if you have difficulty to breath or swallow with or without face, lip, tongue and/or throat swelling.

Inform your doctor if you are going to be admitted to hospital for a surgical intervention. Tell your doctor or dentist that you are taking TENSIKEY before a local or general anaesthetic is administered to you.

Pregnancy and breast-feeding
Contact your doctor or pharmacist before taking a medicine.
TENSIKEY is contraindicated during pregnancy and cannot be used if you are a nursing mother.

Angiotensin-converting enzyme inhibitors (group to which lisinopril belongs) may cause damage and foetal death, when administered during the second and third quarter of pregnancy. If pregnancy is detected, the administration of this medicine must be stopped as soon as possible.

Use in children
The use of TENSIKEY is not recommended in children as information on safety and efficacy in this age group is limited.

Driving and use of machinery
It is unlikely that the tablets of TENSIKEY affect your capacity to drive vehicles or use machines; however, if you notice dizziness or tiredness symptoms, try not to perform tasks that may require special attention until you know how you tolerate the treatment.

Use of other medicines
Inform your doctor if you are taking, or have been taking recently, any other medicine, even over-the-counter medicines.
Bear in mind that these directions may also be applicable for medicines that had been used before or may be used later.

Certain medicines may interact with TENSIKEY; in these cases it may be necessary to change dose or interrupt treatment with some of them.
It is important that you inform your doctor if you are taking or have recently been taking any of the following medicines:

• Diuretics (medicines used to increase urine elimination).
• Potassium supplements or salt substitutes containing potassium.
• Medicines for mental disorders such as lithium, antipsychotics or tricyclic antidepressants.
• Non-steroidal anti-inflammatory drugs (NSAID’s) such as indomethacin and high doses of aspirin (more than 3 grams a day) used for the treatment of arthritis or muscular pain.
• Antihypertensives (medicines reducing high blood pressure).
• Sympathicomimetic medicines (stimulate the central nervous system).
• Medicines for the treatment of diabetes, such as insulin or oral antidiabetics.
• Thrombolytic medicines (prevent the formation of blood clots).

3. HOW TO TAKE TENSIKEY 20 mg tablets

Follow these directions unless your doctor has given you different indications. Remember to take your medicine.

Your doctor should tell you how many tablets you are to take daily and the duration of your treatment with TENSIKEY. Do not stop treatment before.

Adults

- Arterial hypertension
The usual recommended initial dose is 10 mg once daily.
The usual long-term dose is 20 mg once daily.
- Symptomatic heart failure
The usual recommended initial dose is 2.5 mg once daily.
The usual long-term dose is 5 mg up to a maximum of 35 mg once daily.

- Acute myocardial infarction
The usual recommended initial dose is 5 mg the first and the second day after the infarction, followed by 10 mg once daily.

- Renal complications of diabetes
The usual dose is 10 mg or 20 mg once daily.

Patients with impaired renal function
Your doctor should adjust your dose.

Administration route:
• Swallow tablets with water.
• Try to take tablets at the same time every day. No matter you take TENSIKEY before or after meals.
• Do not stop taking your tablets if you feel good, unless your doctor says so.
• Remember: the first dose of TENSIKEY may cause a decrease in blood pressure higher than the decease that there will be when continue treatment. This effect may be noticed in form of dizziness. If so, lying down will help you.

If you consider that the action of TENSIKEY is too strong or weak, contact your doctor or pharmacist.

If you take more TENSIKEY than you should:
If you take more TENSIKEY than you should, immediately contact your doctor or pharmacist. The most frequent symptoms in case of overdose are: hypotension, shock, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough.
In case of overdose or accidental ingestion, contact the Poison Centre.

If you forgot to take TENSIKEY:
Do not take a double dose to compensate the forgotten dose and wait for the following administration.

4. POSSIBLE SIDE EFFECTS

As all medicines, TENSIKEY may have side effects.

The following side effects have been reported according to the next frequency categories:
Frequent: in a percentage between 1% and 10%.
Not very frequent: in a percentage between 0.1% and 1%.
Rare: in a percentage between 0.01% and 0.1%.
Very rare: in a percentage lower than 0.01%.

Blood and lymphatic system disorders:
Rare: reduction in haemoglobin (a blood protein), reduction in haematocrit (blood cell proportion).

Very rare: depression of the bone marrow, anaemia, thrombocytopaenia (higher easiness for the onset of haematoma, changes in some blood cells or components.

Metabolism and nutritional disorders:
Very rare:  decrease in blood glucose.

Nervous system and psychiatric disorders:
Frequent:  dizziness, headache.
Not very frequent: mood alterations, tingling sensation and/or numbness of certain members, vertigo, changes in the taste of things, sleep disorders.
Rare:   mental confusion.

Heart and vascular disorders:
Frequent:  dizziness or bewilderment when standing up fast.
Not very frequent: myocardial infarction or cerebrovascular accident, palpitations, fast heart beats, numbness and spasms in fingers, followed by heat and pain (Raynaud’s phenomenon).

Respiratory disorders:
Frequent: cough.
Not very frequent: rhinitis.
Very rare: panting, sinusitis, lung inflammation.

Digestive disorders:
Frequent:  diarrhoea, vomiting.
Not very frequent: nausea, abdominal pain and indigestion.
Rare:   dry mouth.
Very rare: liver or pancreas inflammation, jaundice (yellowish colour of the skin and/or eyes).

Cutaneous disorders:
Not very frequent: rash, itching.
Rare: intense skin itching (with flat elevations of the skin), hair loss, psoriasis, allergic reaction (angioedema) characterised by face, limb, lip, tongue and/or larynx swelling.
Very rare: sweating, severe cutaneous disorders (whose symptoms may include reddening, ampoules and desquamation).

Occasionally, tiredness or sore throat may occur, which may be accompanied by fever, joint and muscle pain, joint or glandule swelling or sensitivity to sunlight.

Kidney and urine disorders:
Frequent:  changes in the kidney functioning.
Rare:   increase in urea in the urine.
Very rare:  pain when urinating or inability to urinate.
Reproductive system and breast disorders:
Not very frequent: impotence.
Rare:   breast development in men.

General disorders:
Not very frequent: fatigue, tiredness.

Laboratory determinations:
Not very frequent: increase in blood urea, increase in blood creatinine, increase in liver enzymes, increase in blood potassium.
Rare: increase in blood bilirubin, decrease in blood sodium.

If any other side effect not reported in this leaflet is noticed, contact your doctor or pharmacist.

5. PRESERVATION OF TENSIKEY 20 mg tablets

This medicinal product does not require any special preservation conditions.

Keep TENSIKEY 20 mg tablets out of reach and sight of the children.

Expiry
Do not take TENSIKEY 20 mg tablets after the expiry date stated on the package. Give back the TENSIKEY tablets that you have not used to your pharmacist.