Active ingredients: Amlodipine
Amlodipine Actavis 5 mg tablets
Amlodipine Actavis 10 mg tablets
Why is Amlodipine used - Generic Drug? What is it for?
Amlodipine Actavis contains the active substance amlodipine, which belongs to a group of medicines called calcium channel blockers.
Amlodipine Actavis is used to treat high blood pressure (hypertension) or a type of chest pain called angina, including a rare form called Prinzmetal's or variant angina.
In hypertensive patients this drug works by relaxing the blood vessels so that the blood can drain more easily. In patients with angina, Amlodipine Actavis works by improving the blood supply to the heart muscle which then receives more oxygen and thereby prevents chest pain. The drug does not bring about immediate relief of chest pain due to angina.
Contraindications When Amlodipine - Generic Drug should not be used
Do not take Amlodipine Actavis
- if you are allergic (hypersensitive) to adamlodipine or to any of the other ingredients (see section 6), or to any of the calcium channel blockers. The reaction may be itchy, red skin or difficulty in breathing.
- if you have severe low blood pressure (hypotension).
- if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply the body with enough blood).
- if you suffer from heart failure following a heart attack.
Precautions for use What you need to know before taking Amlodipine - Generic Drug
Take special care with Amlodipine Actavis
Tell your doctor if you have or have suffered from the following conditions:
- Recent heart attack
- Heart failure
- Severe increase in blood pressure (hypertensive crisis)
- Liver disease
- He is elderly and his dosage needs to be increased
Use in children and adolescents
Amlodipine has not been studied in children under the age of 6. Amlodipine Actavis is only to be used for hypertension in children and adolescents 6 to 17 years of age (see section 3).
For more information, consult your doctor.Interactions Which drugs or foods can modify the effect of Amlodipine - Generic Drug
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Amlodipine Actavis can affect other medicines, or other medicines can affect Amlodipine Actavis, such as:
- ketoconazole, itraconazole (antifungal medicines)
- verapamil, diltiazem (heart medicines)
- erythromycin, rifampicin, clarithromycin (antibiotics)
- hypericum perforatum (St. John's wort)
- ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV)
- dantrolene (infusion for severe body temperature changes)
- simvastatin (used to reduce high blood cholesterol levels)
Amlodipine Actavis may lower your blood pressure even more if you are already taking other medicines to treat hypertension at the same time.
Taking Amlodipine Actavis with food and drink
People taking Amlodipine Actavis should not drink grapefruit juice as grapefruit and grapefruit juice can cause the levels of the active substance amlodipine to rise in the blood, which may lead to an increase in the hypotensive effect of Amlodipine Actavis.
Warnings It is important to know that:
Pregnancy
The safety of amlodipine in pregnant women has not been established. If you think you are pregnant or planning to become pregnant, tell your doctor before taking Amlodipine Actavis.
Feeding time
It is not known whether amlodipine passes into breast milk. If you are breastfeeding, or will start breastfeeding, you must inform your doctor before taking Amlodipine Actavis.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amlodipine Actavis may have an effect on the ability to drive or use machines. If the tablets make you feel unwell, dizzy or tired, or cause you a headache, do not drive or operate machinery and contact your doctor immediately.
Dose, Method and Time of Administration How to use Amlodipine - Generic Drug: Posology
Always take your medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
The usual starting dose is Amlodipine Actavis 5 mg once daily.
The dose can be increased to 10 mg of Amlodipine Actavis once daily. The drugstore can be taken before or after food and drink. You should take the medicine at the same time each day with some water. Do not take Amlodipine Actavis with grapefruit juice.
Use in children and adolescents
For children and adolescents (6 to 17 years of age), the usual starting dose is 2.5 mg per day. The maximum daily dose is 5 mg per day.
Amlodipine 2.5 mg is not currently available and the 2.5 mg strength cannot be obtained with Amlodipine Actavis 5 mg tablets as these tablets are not manufactured to be divided into equal halves.
Amlodipine 2.5 mg not currently available and the 2.5 mg strength cannot be obtained with Amlodipine Actavis 10 mg tablets as these tablets are not manufactured to be divided into equal four parts.
Continue to take the tablets for as long as your doctor tells you. See your doctor before you run out of tablets.
Overdose What to do if you have taken an overdose of Amlodipine - Generic Drug
If you take more Amlodipine Actavis than you should
And if you take too many tablets, your blood pressure could drop too low and this could be a danger. You may feel dizzy, dizzy, faint or pass out. The drop in blood pressure could be severe enough to shock you. The skin may cool and become clammy and you may lose consciousness. If you have taken too many Amlodipine Actavis tablets, contact your doctor immediately.
If you forget to take Amlodipine Actavis
Do not worry. If you forget to take a tablet, skip the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Amlodipine Actavis
You must continue to take this medicine for as long as your doctor tells you. Stopping treatment can cause the disease to get worse.
Side Effects What are the side effects of Amlodipine - Generic Drug
Like all medicines, Amlodipine Actavis can cause side effects, although not everybody gets them.
If you notice any of the following very rare and serious side effects, see your doctor immediately:
- Sudden onset of wheezing, chest pain, shortness of breath or difficulty in breathing
- Swelling of the eyelids, face or lips
- Swelling of the tongue and throat which can cause difficulty in breathing
- Severe skin reactions including intense skin rash, hives, skin redness all over the body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome) or other allergic reactions
- Myocardial infarction, arrhythmia
- Inflammation of the pancreas which may cause severe abdominal and back pain combined with a feeling of being very unwell.
The following common side effects have been reported. If any of these effects occur or if they persist for more than a week, please contact your doctor.
Common: affects 1 to 10 users in 100:
- Headache, dizziness, somnolence (especially at the start of treatment)
- Palpitations (feeling your own heartbeat), redness
- Abdominal pain, feeling sick, nausea
- Swelling of the ankles (edema), tiredness
In addition, the following side effects have been reported.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Uncommon: may affect 1 to 10 in 1,000 patients:
- Mood changes, anxiety, depression, lack of sleep
- Tremor, changes in taste, fainting, weakness
- Feeling numb or tingling in the limbs loss of pain sensation
- Visual disturbances, double vision, ringing in the ears
- Low blood pressure
- Sneezing / runny nose due to inflammation of the nasal mucosa (rhinitis)
- Altered bowel habits, diarrhea, constipation, indigestion, dry mouth, vomiting
- Hair loss, increased sweating, itchy skin, red patches on the skin, skin discoloration
- Urinary disorders, need to urinate at night, need to urinate often
- Inability to achieve an "erection; discomfort or enlargement of the breasts in men
- Weakness, pain, malaise
- Joint or muscle pain, muscle cramps, back pain
- Weight gain or loss
Rare: may occur in 1 to 10 out of 10,000 patients:
- Confusion
Very rare; may occur in less than 1 in 10,000 patients
- Low levels of white blood cells and platelets in the blood which can lead to "unusual bruising or a tendency to bleed (damage to red blood cells)
- High blood sugar levels (hyperglycemia)
- A nerve disorder that can cause weakness, tingling or numbness
- Cough, swollen gums
- Bloating (gastritis)
- Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increase in liver enzymes which may lead to changes in some medical tests
- Increased muscle tension
- Inflammation of blood vessels, often with skin ruch
- Sensitivity to light
- Disorders related to stiffness, tremor and / or movement disorders
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package after "EXP". The expiry date refers to the last day of that month.
Store in the original package to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. This will help protect the environment.
What Amlodipin Actavis contains
The active substance in Amlodipine Actavis 5 mg tablets is amlodipine (as besylate).
The active substance in Amlodipine Actavis 10 mg tablets is amlodipine (as besylate).
The other ingredients are: microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium starch glycolate (Type A), magnesium stearate.
What Amlodipine Actavis looks like and contents of the pack
5 mg tablets: white to off-white, round and biconvex tablets and debossed with 5 "on one side
10 mg tablets: White to off-white, round and biconvex tablets, scored on one side and debossed with "10" on one side.
The 5 mg tablets are available in pack sizes of 20, 28, 50 and 100 tablets.
The 10 mg tablets are available in pack sizes of 14, 20, 50 and 100 tablets.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
AMLODIPINE ACTAVIS 10 MG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 13.868 mg of amlodipine besylate, which corresponds to 10 mg of amlodipine.
For a full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Tablet.
AMLODIPINE ACTAVIS 10 mg tablets are presented as white to off-white, round and biconvex tablets, approximately 10.5 mm in diameter, with a break line on one side, embossed with "10" on the other side. The tablet can be divided into equal halves.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
• Hypertension
• Stable angina pectoris and vasospastic angina pectoris (Prinzmetal's angina or Variant angina).
04.2 Posology and method of administration
For oral use. The tablets should be taken with a glass of water before or during a meal.
Amlodipine Actavis can be divided into equal halves. The use of a device to divide the tablet is recommended.
Hypertension and angina pectoris
The treatment must be personalized. The starting dose and the usual dose is 5 mg of amlodipine once a day. If the desired therapeutic effect cannot be achieved within 2-4 weeks, the dose can be increased to a maximum of 10 mg amlodipine per day given as a single dose. If a satisfactory clinical response is not achieved within at least 4 weeks additional or alternative therapy should be considered.The dose administered may need to be adjusted if different antihypertensive agents are administered concomitantly.
Elderly patients
No dose adjustment is required in elderly patients, however, dose escalation should be done with caution.
Children with hypertension from 6 years to 17 years
The recommended oral antihypertensive dose in pediatric patients 6 to 17 years of age is 2.5 mg once daily as a starting dose, increased to 5 mg once daily if therapeutic effect is not achieved after 4 weeks. Doses above 5 mg per day have not been studied in pediatric patients (see section 5.1 "Pharmacodynamic properties" and 5.2 "Pharmacokinetic properties"). The effect of amlodipine on blood pressure in patients younger than 6 years.
The 2.5 mg dose cannot be obtained with "Amlodipine Actavis" 5 mg tablets as these tablets are not manufactured to be divided into equal halves.
Hepatic impairment
A reduced dose should be used in patients with hepatic impairment (see sections 4.4 and 5.2).
Renal impairment
Normal dosage is recommended (see section 5.2). Amlodipine is not dialysable. Amlodipine should be administered with particular caution to patients on dialysis (see section 4.4).
04.2 Posology and method of administration
04.3 Contraindications
Amlodipine Actavis tablets are contraindicated in:
• patients with known hypersensitivity to amlodipine, to other dihydropyridines or to any of the excipients,
• severe hypotension,
• shock,
• heart failure after acute myocardial infarction (during the first 28 days),
• obstruction of the outflow tract of the left ventricle (for example, high degree of aortic stenosis),
• unstable angina pectoris.
04.4 Special warnings and appropriate precautions for use
There are no supportive data on the use of amlodipine alone, during or within the first few months after myocardial infarction. The safety and efficacy of amlodipine in hypertensive crisis have not been established.
Use in patients with heart failure
Patients with heart failure should be treated with caution. A long-term study including patients with severe heart failure (NYHA class III and IV) showed an "increased incidence of pulmonary edema in patients treated with amlodipine compared to the placebo group. However, this does not indicate an aggravation of the insufficiency". cardiac (see section 5.1).
Use in patients with renal impairment
Amlodipine is not dialysable. Amlodipine should be administered with particular caution to patients on dialysis.
Use in patients with impaired hepatic function
The terminal half-life of amlodipine is prolonged in patients with impaired hepatic function; dosing recommendations have not yet been established. Therefore, amlodipine should be administered with caution in these patients.
Use in elderly patients
Caution is recommended in elderly patients when the dosage is increased (see section 5.2).
Use in children under 6 years of age
Amlodipine should not be given to children due to insufficient clinical experience.
04.5 Interactions with other medicinal products and other forms of interaction
Amlodipine may potentiate the effect of other antihypertensive drugs such as beta-adrenoceptor blocking agents, ACE inhibitors, alpha-1 blockers and diuretics.
In patients with increased risk (e.g. after myocardial infarction) the combination of a calcium channel blocker with a beta-adrenoceptor blocking agent may lead to heart failure, hypotension and a (new) myocardial infarction.
A study in elderly patients showed that diltiazem inhibits the metabolism of amlodipine, possibly via CYP3A4, as the plasma concentration is increased by approximately 50% and the effect of amlodipine is enhanced. It cannot be excluded that more potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) increase the plasma concentration of amlodipine to a higher degree than diltiazem. Caution should be used when combining amlodipine with CYP3A4 inhibitors.
No information is available on the effect of CYP3A4 inducers (eg rifampicin, St John's wort) on amlodipine. Co-administration may lead to decreased plasma concentrations of amlodipine. Caution should be used when combining amlodipine with CYP3A4 inducers.
Concomitant administration of 240 ml of grapefruit juice with 10 mg of amlodipine did not show a significant effect on the pharmacokinetic properties of amlodipine.
In clinical interaction studies, amlodipine did not affect the pharmacokinetic properties of atorvastatin, digoxin, warfarin or cyclosporine.
Amlodipine does not affect laboratory parameters.
04.6 Pregnancy and lactation
There are no adequate data on the use of amlodipine in pregnant women. Animal studies have shown reproductive toxicity at high doses (see section 5.3). The potential risk for humans is unknown. Amlodipine should not be used during pregnancy unless the therapeutic benefit clearly outweighs the potential risks of treatment.
It is not known whether amlodipine is excreted in breast milk. Similar calcium channel blockers of the dihydropyridine type are excreted in breast milk. There is no experience of the risk this may be to the infant, therefore, as a precaution, do not you must breastfeed during treatment.
04.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. In patients suffering from dizziness, headache, fatigue or nausea, the ability to react may be impaired.
04.8 Undesirable effects
The following terminologies have been used to classify the frequency of undesirable effects:
Cardiac pathologies
Common: palpitations.
Uncommon: syncope, tachycardia, chest pain.
Worsening of angina pectoris may occur at the start of treatment.
Isolated cases of myocardial infarction and arrhythmias (including extrasystole, tachycardia and atrial arrhythmia) and chest pain have been reported in patients with coronary artery disease, but a clear association with amlodipine has not been established.
Disorders of the blood and lymphatic system
Uncommon: leukopenia, thrombocytopenia.
Nervous system disorders
Common: headache (especially at the beginning of treatment), fatigue, dizziness, asthenia.
Uncommon: malaise, peripheral neuropathy, dry mouth, paraesthesia, sweating increased.
Rare: hypertonia, changes in taste.
Very rare: tremor.
Eye disorders
Uncommon: visual disturbances.
Ear and labyrinth disorders
Uncommon: tinnitus.
Respiratory, thoracic and mediastinal disorders
Common: dyspnoea, rhinitis.
Uncommon: cough.
Gastrointestinal disorders
Common: nausea, dyspepsia, abdominal pain.
Uncommon: vomiting, diarrhea, constipation, gingival hyperplasia.
Very rare: gastritis.
Renal and urinary disorders
Uncommon: increased frequency of urination.
Skin and subcutaneous tissue disorders
Very common: swelling of the ankles.
Common: flushing of the face with a sensation of heat, especially at the beginning of treatment.
Uncommon: rash, pruritus, urticaria, alopecia.
Rare: purpura, skin discoloration.
Very rare: angioedema.
There have been isolated reports of allergic reactions including pruritus, rash, angioedema and exudative erythema multiforme, exfoliative dermatitis and Stevens Johnson syndrome, Quincke's edema.
Musculoskeletal and connective tissue disorders
Common: muscle cramps.
Uncommon: back pain, myalgia and arthralgia.
Endocrine pathologies
Uncommon: gynecomastia.
Metabolism and nutrition disorders
Very rare: hyperglycaemia.
Vascular pathologies
Uncommon: hypotension, vasculitis.
General disorders and administration site conditions
Uncommon: weight gain or decrease.
Rare: edema.
Hepatobiliary disorders
Uncommon: pancreatitis.
Rare: increased elevated liver enzymes, jaundice, hepatitis.
Diseases of the reproductive system and breast
Uncommon: impotence.
Psychiatric disorders
Uncommon: sleep disturbances, irritability, depression.
Rare: confusion, mood changes including anxiety.
04.9 Overdose
Experience of overdose with amlodipine is limited. Excessive doses of amlodipine can cause peripheral vasodilation with marked hypotension. Circulatory support may be required. Cardiac and respiratory activity should be closely monitored. Intravenous calcium glubionate may be useful in hypotension due to cardiogenic shock and arterial vasodilation. Since amlodipine is highly bound to plasma proteins, dialysis is not considered important.
Gastric lavage or the administration of activated charcoal may be useful in some cases.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: dihydropyridine derivatives.
ATC code: C08CA01
The active substance in Amlodipine Actavis, the dihydropyridine derivative amlodipine, is a chiral substance composed of a raceme. Amlodipine is a calcium antagonist that inhibits the transmembrane flow of calcium ions through L-type voltage gated channels in the heart and smooth muscle. Amlodipine acts on hypertension through a direct relaxing effect on arterial smooth muscle. Animal studies demonstrated that amlodipine is relatively vaso-selective with significantly less effect on cardiac muscle than on vessel smooth muscle. Amlodipine does not impair atrioventricular conduction and does not exhibit a negative inotropic effect. Amlodipine reduces renal vascular resistance and increases renal plasma flow. Amlodipine can be administered to patients with coexisting compensated heart failure. Controlled studies on haemodynamic effects and exercise tolerance in patients with class II-IV heart failure have shown that amlodipine does not cause clinical deterioration in tolerance. to exertion, the ejection fraction of the left ventricle and the clinical symptoms.
No metabolic effects, e.g. on plasma lipids or glucose metabolism, were observed during treatment with amlodipine.
Antihypertensive effect
Amlodipine acts on hypertension through a direct relaxing effect on the smooth muscle of the arterial vessels. Dosing once daily produces a reduction in blood pressure that lasts for 24 hours. The antihypertensive effect follows normal diurnal changes in blood pressure with very small changes over 24 hours. Treatment of at least 4 weeks is required for maximum effect. Amlodipine is effective in supine, sitting and standing positions and during a physical exercise.
Because the pharmacological effect of amlodipine begins slowly, it does not cause acute hypotension or reflex tachycardia. Treatment with amlodipine produces regression of left ventricular hypertrophy. The haemodynamic effects of amlodipine remain unchanged during long-term treatment. There are no long-term morbidity studies available.
Amlodipine can be used in combination with beta blockers, saluretics, ACE inhibitors or alone.
In a study involving 268 children aged 6-17 years with predominantly secondary hypertension, the comparison of a 2.5 mg dose and a 5.0 mg dose of amlodipine with placebo showed that both doses reduced systolic blood pressure significantly more than placebo. The difference between the two doses was not statistically significant.
The long-term effects of amlodipine on growth, puberty and general development have not been studied.
The long-term efficacy of pediatric amlodipine therapy to reduce cardiovascular morbidity and mortality in adulthood has not yet been established.
Antianginal effects
Amlodipine dilates peripheral arterioles, reducing total peripheral resistance (afterload). Since heart rate is unaffected, the reduced load on the heart leads to a reduction in myocardial oxygen demand and energy consumption.
Amlodipine probably dilates coronary vessels, both in ischemic and normally oxygenated areas. This dilation increases the oxygen supply to the myocardium in patients with coronary artery spasms (Prinzmetal's or Variant angina).
In patients with stable angina pectoris, amlodipine once daily increases total exercise tolerance, the time to onset of an anginal attack, and the time to onset of ST segment depression by 1 mm. anginal attacks and the use of nitroglycerin.
Effectiveness during angina pectoris is at least 24 hours.
Amlodipine can be used in combination with beta-blockers, nitrates or alone in angina pectoris.
A placebo-controlled study (PRAISE) designed to evaluate NYHA class III-IV heart failure patients treated with digoxin, diuretics and ACE-inhibitors, showed that amlodipine does not cause any increased risk of death or combined risk. of mortality and morbidity in patients with heart failure.
A follow-up study (PRAISE 2) showed that amlodipine has no effect on total or cardiovascular mortality in patients with non-ischemic class III-IV heart failure. In this study, treatment with amlodipine was associated with an increase in pulmonary edema, although this could not be associated with an increase in symptoms.
05.2 "Pharmacokinetic properties
Absorption and distribution
Bioavailability is 64-80%. Bioavailability is not affected by concomitant food intake. Peak plasma concentrations are achieved, using the recommended doses, within 6-12 hours. The volume of distribution is approximately 21 L / kg. Plasma protein binding is high (98%).
Biotransformation and elimination
The plasma half-life varies between 35 and 50 hours and the steady-state concentration is reached after 7-8 days. Only minimal changes between peak and trough values of plasma concentrations have been observed. Plasma clearance is 7 ml / min / kg. Amlodipine is metabolised almost completely in the liver to exclusively inactive metabolites, of which 60% is excreted in the urine. Approximately 10% of the parent compound is excreted in the urine in an unmetabolized form.
Patients with hepatic insufficiency
The half-life of amlodipine is prolonged in patients with impaired hepatic function (see section 4.4).
Patients with renal impairment and elderly patients
Changes in plasma concentrations of amlodipine are not related to the degree of renal impairment. Amlodipine is not dialyzed due to the high degree of binding to plasma proteins. amlodipine is slightly lower in the elderly. The half-life and AUC in patients with heart failure were, as expected, increased in the age group evaluated.
Children and adolescents
A population pharmacokinetic study was conducted in 74 hypertensive children aged 12 months to 17 years (with 34 patients aged 6 to 12 years and 28 patients aged 13 to 17 years) treated with doses of amlodopine including between 1.25 mg 20 mg administered once or twice a day. In children 6 to 12 years of age and adolescents 13 to 17 years of age, the typical oral clearance (CL / F) was 22.5 L / hr and 27.4 L / hr in males and 16.4 l / hr and 21.3 l / hr respectively in males 16.4 l / hr and 21.3 l / hr respectively in females. A "wide variability in exposure" was observed between individuals. Data reported in children less than 6 years of age are limited.
05.3 Preclinical safety data
Toxicity studies on animals reveal no particular risk for humans in relation to safety pharmacology, genotoxicity, carcinogenicity and repeated dose studies. Harmful effects have been reported in reproductive toxicity studies on animals. Effects in rats (prolonged period pregnancy and difficult delivery) did not reveal any evidence of a direct teratogenic effect, but indicate secondary consequences of pharmacodynamic effects. The significance of these effects for humans is unknown.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Microcrystalline cellulose
Anhydrous dibasic calcium phosphate
Sodium carboxymethyl starch (type A)
Magnesium stearate
06.2 Incompatibility
Not relevant.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
Store in the original packaging.
06.5 Nature of the immediate packaging and contents of the package
PVC / PE / PVDC blisters and aluminum foil
Amlodipine Actavis 10 mg is available in packs of 14, 20, 50 and 100 tablets.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Actavis Group ehf - Reykjavikurvegi 76-78, 220 Hafnarfjöδur (Iceland)
08.0 MARKETING AUTHORIZATION NUMBER
Amlodipina Actavis 10 mg tablets - 14 tablets - AIC n. 037968056 / M
Amlodipina Actavis 10 mg tablets - 20 tablets - AIC n. 037968068 / M
Amlodipina Actavis 10 mg tablets - 50 tablets - AIC n. 037968070 / M
Amlodipina Actavis 10 mg tablets - 100 tablets - AIC n. 037968082 / M
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Determination N. 685/2007 of 18.12.2007 - Ordinary supplement to the Official Gazette n. 302 of 31.12.2007
10.0 DATE OF REVISION OF THE TEXT
March 2012
