Adicanil® - Pharmathen

Adicanil ® LISINOPRIL
PATIENT INFORMATION LEAFLET
1. DESCRIPTION OF THE MEDICINAL PRODUCT
1.1 Name: ADICANIL
1.2 Composition: Active substance: Lisinopril.
Excipients: Mannitol, Dibasic Calcium Phosphate, Starch Maize, Starch Maize Pregelatinized, Magnesium Stearate.
1.3 Pharmaceutical form: Tablets for oral administration.
1.4 Strength: 20 mg/ tab: Each ADICANIL tablet contains 20 mg LISINOPRIL (21.78 mg LISINOPRIL DIHYDRATE corresponds to 20 mg LISINOPRIL).
1.5 Description - Package:
1) Cardboard box containing 1 transparent PVC and aluminium blister with 10 tablets of 20 mg Lisinopril (white). The box also contains the patient information
leaflet.
2) Cardboard box containing 3 transparent PVC and aluminum blisters with 30 tablets of 20mg Lisinopril (white). The box also contains the patient information
leaflet.
1.6 Pharmacotherapeutic category: Anti-hypertensive medicine, inhibitor of Angiotensin Conversional Enzyme (ACE).
1.7 Marketing Authorization Holder: PHARMATHEN S.A. - 6, Dervenakion Str., GR 153 51, Pallini, Tel.: +30.210.6665067
1.8 Manufacturer: PHARMATHEN S.A. - 6, Dervenakion Str., GR 153 51, Pallini, Tel.: +30.210.6665067
2. WHAT YOU SHOULD KNOW ABOUT THE MEDICINE YOUR DOCTOR HAS PRESCRIBED FOR YOU
2.1 General information:
The information of the present leaflet refers only to the specific medicine administered by your doctor, ADICANIL.
Please, read the leaflet carefully. It will provide important information. However, the leaflet cannot explain everything so in case you have questions or are uncertain
about something, ask your doctor or pharmacist.
ADICANIL belongs in a group of medicines called Inhibitors of Angiotensin Conversional Enzyme. ADICANIL dilates vessels and therefore helps reducing arterial
pressure. It also facilitates the heart in sending blood to all parts of your body.
2.2 Indications:
Your doctor has administered ADICANIL because of one of the following reasons: ●High arterial pressure (hypertension) ●Symptomatic heart failure during which
your heart is unable to send blood to your entire body as good as it did before. ●The myocardial infarction you have suffered may reduce your heart’s functionality.
ADICANIL decelerates this reduction. ●Renal disease caused by diabetes and high arterial pressure.
2.3 Contraindications:
Do not receive ADICANIL in case: ●You are pregnant. ●You have already received a medicine belonging in the same category as ADICANIL (inhibitor of Angiotensin
Conversional Enzyme) and presented allergic reactions such as swelling of the hands, legs or ankles, face, lips, tongue and/ or throat with difficulty in swallowing
or breathing or in case any other member of your family has presented the same reaction. ●You have ever presented an allergic type reaction to LISINOPRIL or
any other medicine of the same group.
Notify your doctor in case you are uncertain whether you should start receiving ADICANIL or not.
2.4 Special precautions and warnings for use:
2.4.1 General:
Before receiving your medicine, notify your doctor of any health problems. Specifically report if you present:
●Aortic stenosis, stenosis of the renal arteries or stenosis of the heart valves and hypertrophic myocardiopathy. ●Other health problems such as problems with
your kidneys or are undergoing hemodialysis. ●Hepatic malfunction. ●Vascular disease (collagen disease) and/ or treatment with allopurinol (for uric arthritis),
procainamide (for arrhythmias) and immunosuppressive medicines (medicines that suppress the immune system). ●Diarrhoea or vomit
Also, report if you are on a restricted in salt diet or if you are receiving potassium supplements.
STOP RECEIVING ADICANIL and immediately notify your doctor in any of the following cases:
●If you present swelling on your face, lips, tongue and/ or throat that makes it difficult for you to breath. If you present swelling on your face, lips, tongue and/ or
throat that makes it difficult for you to swallow. ●If you present severe itching on your skin (appearance of swelling).
Inform your doctor if you are under any desensitization treatment for allergies after a sting (p.e bee or wasp sting) because in several such cases, administration of
ACE inhibitors during desensitization treatment may cause an even more severe allergic reaction.
Before any surgical operation and anesthesia (even a dental one), notify the doctor or dentist of the use of ADICANIL as sudden reduction in arterial pressure may
occur, relating to the anesthesia.
Extreme caution is required when receiving the first dose of ADICANIL. It may cause great reduction in arterial pressure, greater that the one usually noted during
continuous treatment.
ADICANIL should not be administered in children under the age of 18. Safety and effectiveness in children has not yet been documented.
2.4.2 Pregnancy:
Contact your doctor in case you are pregnant or plan to get pregnant. ADICANIL should not be administered during pregnancy.
2.4.3 Lactation:
Contact your doctor if you are breastfeeding. ADICANIL should not be administered during lactation.
2.4.4 Children:
ADICANIL should not be administered in children.
2.4.5 Effects on ability to drive and use machines:
It is considered impossible for ADICANIL tablets to affect the ability to drive and use machines.
However, you should not get occupied with projects that require particular attention until you are aware of your tolerance to the medicine.
Notify your doctor in case you are uncertain whether you should start receiving ADICANIL or not.
2.4.6 Special warnings for excipients:
Do not receive the medicine if you know you are allergic to any of its excipients.
2.5 Interactions with other medicinal products or substances:
Before receiving your medicine, notify your doctor of any other medicines you are receiving, including those bought without a prescription such as nutrition supplements.
There may be interaction. In particular, notify your doctor if you are receiving:
● Diuretics (including medicines for the maintenance of potassium levels).
● Other medicines for the treatment of high arterial pressure (anti-hypertensive medicines).
● Non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin and high doses of aspirin (> 3gr/daily) that are used in the treatment of arthritis or muscular
pain.
● Medicines for psychiatric diseases such as antipsychotic or tricyclic antidepressants.
● Potassium tablets or salt substitutes that contain potassium.
● Antidiabetic medicines such as insulin or medicines that are being orally administered for reducing sugar levels.
● Medicines that activate the central nervous system (sympathomimetic medicines). They include ephedrine, pseudoephedrine and salbutamole and they may be
found in some antacids, as well as in medicines for asthma and cold.
● Medicines that suppress the immune system (immunosuppressive medicines), allopurinol (for uric arthritis) or procainamide (for arrhythmias).
2.6 Posology:
Follow your doctor’s instructions on when and how to receive tablets according to the prescription. The dose is individual and it is important to always take your
medicine. The initial posology, as well as the long-term one, depends on your clinical response to the medicine and on the other medicines you are receiving.
In case you are not sure, ask your doctor or pharmacist.
High Arterial Pressure: The usual initial dose is 10mg administered once daily. The usual long-term dose is 20mg once daily.
Symptomatic Heart Failure: The usual recommended initial dose is 2,5mg administered once daily. The usual long-term dose is 5-35mg administered once
daily.
After a Myocardial Infarction: The usual recommended initial dose is 5mg on the first and second day and then, 10mg once daily.
Problems relating to Diabetes Mellitus: The usual posology range is 10-20mg daily.
ADICANIL method of administration
● Swallow the tablet with a glass of water.
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● Try to take your tablets on the same hour every day. Tablets may be administered before or after meals.
● Do not stop receiving your tablets, even if your arterial pressure is restored to normal levels and you feel well, unless otherwise instructed by your doctor.
● Remember that the initial dose may cause a much greater reduction in arterial pressure than continuous treatment. This may be noted as weakness or dizziness.
Lying down might help you. If you are worried, consult your doctor as soon as possible.
● If you feel that ADICANIL’s effect is very strong or very weak, consult your doctor or pharmacist as soon as possible.
2.7 Overdose - Treatment:
If you receive more tables than your regular dose, consult your doctor or visit the nearest hospital.
2.8 Undesirable effects:
As with all medicines, undesirable effects may occur with the use of ADICANIL. The list of undesirable effects should not worry you. You may not present any of
them. Most patients present no undesirable effects. However, if you notice something that bothers you, notify your doctor.
The most common undesirable effects that may occur are (in > 1% of the patients up to < 10% meaning 1 out of 10 and 1 out of 100 patients):
●Headache
●Cough
●Dizziness or feeling of head vacuum (when you suddenly get up)
●Vomit
●Diarrhea
●Lisinopril may affect the function of the kidneys causing oliguria or anuria.
Less common undesirable effects are (0,1% or < 1%, meaning 1 out of 100 patients or 1 out of 1000 patients):
●Change of mood
●Stomach pain or dyspepsia
●Pins and needles on fingers or toes
●Skin rash
●Somnolence or difficulty in sleeping, strange dreams
●Itching
●Change of taste
●Impotence
●Fast heartbeat
●Fatigue
●Cold
●Weakness
●Nausea
Great reduction in arterial pressure may be caused in patients with coronary disease, aortic stenosis, stenosis of the renal arteries or stenosis of the heart valves
and hypertrophic myocardiopathy.
Rare undesirable effects (in > 0,01% and < 0,1% meaning 1 out of 1000 and 1 out of 10.000 patients) are:
●Allergic reactions
STOP RECEIVING ADICANIL and immediately notify your doctor in any of the following cases:
●If you present swelling of the face, lips, tongue and/ or throat that makes it difficult for you to breath or swallow.
●If you present severe skin itching (appearance of swelling).
In rare occasions, changes in some cells or other parts of the body may be reported. It is possible for your doctor to periodically take blood samples in order to
examine if lisinopril affects your blood.
Sometimes, these changes are manifested as fatigue or irritated throat or they may be accompanied by fever, joint and muscle pain, swelling of the joints or
photosensitivity.
Other rare undesirable effects are:
●Confusion ●Dry mouth ●Alopecia ●Psoriasis.
Very rare undesirable effects may also appear (< 0,01% meaning less than 1 out of 10.000 patients).
●Pain at the antrum
●Irritation of the liver or pancreas
●Whistling respiration
●Severe skin diseases (symptoms that include redness, blisters and peeling)
●Yellow skin and/ or eyes (jaundice)
●Perspiration
Notify your doctor in case you present other undesirable effects not listed above.
2.9 What the patient should do in case of a missed dose:
You must use ADICANIL according to the doctor’s instructions. However, in case you miss a dose, do not receive an extra one as a replacement. Follow your
regular schedule.
2.10 Product expiry date: Expiry date is inscribed on the outer and inner package.
2.11 Special precautions for storage:
Store in a cool and dry place at temperature up to 25º C. Keep out of the reach and sight of children.
2.12 Date of last revision of the text: Prot. No.: 45670/22-7-2005
3. INFORMATION REGARDING THE CORRECT USE OF MEDICINES
● This medicine has been prescribed to you by your doctor and only for your specific medical problem. You should not give it to other people or use it for a
different disease, without first consulting your doctor.
● In case during treatment, any problem appears regarding the medicine, notify your doctor or pharmacist.
● If you have any questions regarding the information related to the medicine you receive or if you need to be better informed of your medical problem, do not
hesitate to ask your doctor of pharmacist.
● In order for the medicine administered to you to be effective and safe, it should be taken according to the given instructions.
● For your safety and health, it is necessary to carefully read all information related to the medicine.
● Do not keep medicines in bathroom cupboards because heat and moisture may alter them and place them as harmful for your health.
● Keep medicines in their original container.
● If your doctor decides that you should discontinue treatment, dispose of the remaining medicine.
● Do not use medicines after the expiry date inscribed on the container has passed. Dispose of them.
● Keep all medicines in a safe place out of the reach and sight of children. The medicine may harm children.
4. Legal category: Adicanil is a prescription only medicine.
5. Product License Number: ADICANIL 20 MG/ TAB: 25459/04/20-5-2005
MANUFACTURED BY
PHARMATHEN S.A. - 6, DERVENAKION STR.
153 51 PALLINI, ATTICA, GREECE - TEL.: +30.210.6665.067
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