NORMODIPINE 10 mg. 30 tablets

What is Normodipin and what it is used
Normodipin contains the active ingredient amlodipine, which belongs to a group of medicines called calcium channel blockers.
Normodipin is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, rare forms of which are of Prinzmetal angina or variant angina.
In patients with high blood pressure act by expanding the blood vessels so that the blood flows through them more easily. In patients with angina Normodipin works by improving blood supply to the heart muscle, which thus receives more oxygen and as a result chest pain is prevented. Your medicine does not provide quick relief of chest pain from angina.

2. What you need to know before taking Normodipin
Do not take Normodipin:
if you are allergic to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to other calcium channel blockers. This can be expressed in itching, redness of the skin or difficulty in breathing;
if you have very low blood pressure (hypotension);
if you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which your heart can not supply enough blood to the body);
if you suffer from heart failure after a heart attack.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Normodipin
You should tell your doctor if you have or have recently had any of the following:
Recently a heart attack;
Heart failure;
Severe increase in blood pressure (hypertensive crisis);
You are elderly and your dose needs to be increased.
Children and adolescents
Normodipin not been studied in children under 6 years of age. Normodipin should be used only in hypertension in children and adolescents aged 6 to 17 years (see. Point 3).
For more information, ask your doctor.

Other medicines and Normodipin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Normodipin can affect or be affected by other drugs such as:
ketoconazole, itraconazole (antifungal medicines);
ritonavir, indinavir, nelfinavir (m. called. protease inhibitors for the treatment of HIV);
rifampicin, erythromycin, clarithromycin (antibiotics);
Hypericum perforatum (St. John's Wort);
verapamil, diltiazem (heart medicine);
dantrolene (infusion for severe abnormalities in body temperature);
simvastatin (for reducing the amount of fatty substances in the blood).
Normodipin can lower your blood pressure if you are already taking other medicines to treat high blood pressure.

Taking Normodipin with food and drink
People taking Normodipin should not consume grapefruit juice or grapefruit. The reason for this is that these products can lead to higher levels of the active ingredient amlodipine in the blood, which may cause unpredictable enhancement of the antihypertensive effect of Normodipin.

Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
The safety of amlodipine in human pregnancy has not been established.
It is not known whether amlodipine passes into breast milk. If you are breastfeeding or about to start breast-feeding, you should tell your doctor before taking Normodipin.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
Normodipin can affect your ability to drive or operate machinery. If your tablets cause nausea, dizziness or fatigue or cause headache, do not drive or operate machinery and contact your doctor immediately.

3. How to take Normodipin
Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
The recommended starting dose is Normodipin 5 mg once daily. The dose may be increased to Normodipin 10 mg once daily.
Your medicine can be taken before or after food and drinks. You should take your medicine at the same time each day with a glass of water. Normodipin not take with grapefruit juice.

Use in children and adolescents
In children and adolescents (6-17 years old), the recommended usual starting dose is 2,5 mg per day. The maximum recommended dose is 5 mg daily. Normodipin 2,5 mg is not available at the time and the dose of 2,5 mg can be obtained from Normodipin 5 mg tablets, since these tablets are not produced so as to be divided into two identical halves.
It is important to continue taking the tablets. Do not wait for the tablet to do, to see your doctor.

If you take more dose Normodipin
Taking too many tablets can lead to low or even dangerously low blood pressure. You may experience dizziness, vertigo, fatigue or weakness. If the decrease in blood pressure is severe, can lead to shock. You may feel your skin clammy and lose consciousness. Seek medical attention if you take too many tablets Normodipin.

If you forget to take Normodipin
Do not be nervous. If you forget to take a tablet, leave out that dose. Take your next dose at the appropriate time. Do not take a double dose to make up the missed dose.

If you stop taking Normodipin
Your doctor will advise you on how long to take your medicine. Your condition may return if you stop taking the medication before you told your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can also cause side effects, although not everybody gets them.

Visit your doctor immediately if you experience any of the following rare but serious side effects after taking this medicine:
Sudden wheezing, chest pain, shortness of breath or difficulty breathing;
Swelling of eyelids, face or lips;
Swelling of the tongue and throat that very difficult to breathe;
Severe skin reactions including intense skin rash, hives, redness of the skin of the whole body, severe itching, blistering, peeling and swelling of the skin, mucosal inflammation (syndrome of Stevens Johnson) or other allergic reactions;
Heart attack, irregular heart beat;
Inflamed pancreas, which can cause severe abdominal pain and back pain accompanied by severe malaise.
Reported the following common side effects. If any of these cause you problems or last more than a week, you should contact your doctor.
Common: may affect up to 1 in 10 people:
Headache, dizziness, sleepiness (especially at the beginning of treatment);
Palpitations (awareness of the heartbeat), flushing;
Abdominal pain, feeling sick (nausea);
Swelling of the ankles (edema), fatigue.
Other reported adverse reactions are listed below. If one of them gets serious, or if you notice any not listed in this leaflet, please tell your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people:
Mood changes, anxiety, depression, insomnia;
Tremor, taste changes, fainting, weakness;
Numbness or tingling in the limbs; loss of sensation of pain;
Visual disturbances, double vision, ringing in the ears;
Low blood pressure;
Sneezing / runny nose caused by inflammation of the lining of the nose (rhinitis);
Change in normal bowel movements, diarrhea, constipation, indigestion, dry mouth, vomiting (nausea);
Hair loss, increased sweating, itchy skin, red spots on the skin, change in skin color;
Abnormal urination, frequent urination at night, increased frequency of urination;
Inability to obtain an erection; discomfort or breast enlargement in men;
Weakness, pain, malaise;
Joint or muscle pain, muscle cramps, back pain;
Increase or decrease in body weight.
Rare: may affect up to 1 in 1,000 people:
Confusion.
Very rare: may affect up to 1 in 10,000 people:
Low white blood cell count, low platelet count in the blood which may lead to unusual bruising or bleeding easily (damage to red blood cells);
High blood sugar (hyperglycemia);
Disorder affecting the nerves which can cause weakness, tingling or numbness;
Cough, swelling of the gums;
Bloating (gastritis);
Impaired liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which may interfere with some laboratory tests;
Increased muscle tension;
Inflammation of blood vessels, often with skin rash;
Sensitivity to light;
Disorders, including stiffness, tremor (shaking) and / or movement disorders.
If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.

5. How to store Normodipin
Store in the original package.
Keep out of the reach and sight of children.
Do not use this medicine after the expiration date (EXP :) stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Normodipin
The active substance is:
5 mg tablets:
Each tablet contains 5,00 mg amlodipine (amlodipine) (in the form of 6,944 mg of amlodipine besylate).

10 mg tablets:
Each tablet contains 10,00 mg amlodipine (amlodipine) (in the form of 13,889 mg amlodipine besylate).