Consumer medicine information

APX-Amlodipine (was Amlodipine APOTEX) 10 mg Tablets

Amlodipine

BRAND INFORMATION

Brand name

APX-Amlodipine (was Amlodipine APOTEX)

Active ingredient

Amlodipine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APX-Amlodipine (was Amlodipine APOTEX) 10 mg Tablets.

What is in this leaflet


This leaflet answers some common questions about amlodipine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may want to read it again.

What this medicine is used for


Amlodipine is used to lower high blood pressure (hypertension) or treat angina. It belongs to a group of medicines called calcium channel blockers.

How it works


Amlodipine works by widening your blood vessels, making it easier for your heart to pump blood around the body and help increase the supply of blood and oxygen to your heart.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
There is not enough information to recommend using amlodipine in children.

Before you take this medicine

When you must not take it


Do not take this medicine if you have an allergy to:
  • amlodipine
  • other calcium channel blockers such as medicines with the active ingredient felodipine, nifedipine or lercanidipine.

Check with your doctor or pharmacist if you are unsure.
  • or any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:
  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue, throat or other parts of the body
  • rash, itching or hives on the skin

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it


Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
  • liver problems
  • heart disease or heart failure

Tell your doctor if you are pregnant or plan to become pregnant.
Do not take this medicine until you and your doctor have discussed the risks and benefits involved.
Do not breast-feed if you are taking this medicine.
The active ingredient in this medicine passes into breast milk. Your baby may be affected.
Tell your doctor if you are planning to have surgery, dental treatment or an anaesthetic.
If you have not told your doctor about any of the above, tell them before you start taking this medicine.

Taking other medicines


Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may be affected by this medicine or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines. Your doctor will advise you.
Tell your doctor or pharmacist if you are taking any of the following:
  • other medicines used to treat angina (e.g. diltiazem)
  • some medicines used to treat infections (e.g. erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole)
  • anti-proteases used to treat HIV infection (e.g. ritonavir)
  • simvastatin, used to lower cholesterol
  • cyclosporin, tacrolimus, sirolimus or everolimus, used to suppress the immune system
  • temsirolimus, a medicine used to treat kidney cancer
  • St John's Wort

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take this medicine


Follow carefully all directions given to you by your doctor.
They may differ to the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How much to take


Your doctor will tell you how many tablets to take each day, depending on your condition and whether you are taking other medicines.
The usual dose is 5 mg each day. Your doctor may increase this to 10 mg each day.
Your doctor may prescribe another dose of Norvasc depending on your condition and how you respond to this medicine.

How to take it


Swallow the tablet with a full glass of water.

When to take it


Take this medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
It does not matter if you take this medicine with or without food.

How long to take it for


Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition but does not cure it. It is important to keep taking your medicine even if you feel well.
Make sure you have enough to last over weekends and holidays.

If you forget to take it


If it is less than 12 hours before your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise take it as soon as you remember and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)


Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too many tablets, you may feel dizzy, lightheaded or faint and have an irregular heartbeat.

While you are taking this medicine

Things you must do


If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
If you become pregnant while taking amlodipine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.

Things you must not do


Do not give this medicine to anyone else, even if they have the same condition as you.
Do not take your medicine to treat any other complaint unless your doctor or pharmacist tells you to.
Do not stop taking your medicine, or change the dosage, without first checking with your doctor.

Things to be careful of


Avoid eating large quantities of grapefruit or drinking large quantities of grapefruit juice.
Grapefruit juice contains one or more components that alter the metabolism of some medicines, including amlodipine. Drinking very large quantities (over 1.2 litres) of grapefruit juice each day while taking Amlodipine may increase the effects of this medicine.
Be careful when driving or operating machinery until you know how amlodipine affects you.
Amlodipine may cause dizziness or drowsiness in some people and affect alertness. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Side effects


Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking amlodipine.
This medicine helps most people, but it may have unwanted side effects in a few people All medicines can have side effects. Sometimes they are serious, most of the time they are not.
Do not be alarmed by the lists of side effects. You may not experience any of them.
If you are 65 years or older, you should be especially careful while taking amlodipine. Report any side effects promptly to your doctor.
Some people in this age group may be more likely to experience side effects such as swelling of the feet and ankles, muscle cramps and dizziness.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor and pharmacist if you notice any of the following and they worry you:

  • headache
  • dizziness
  • flushing
  • tiredness, drowsiness or sleepiness
  • stomach pain or nausea.

The above list includes the more common side effects. Mostly, these are mild.
Tell your doctor if you experience any of the following:
  • indigestion
  • sexual problems

These may or may not be due to amlodipine, but you should tell your doctor.
Tell your doctor as soon as possible if you notice any of the following:
  • changes in heartbeat, either fast or slow
  • swelling of the ankles, feet, face or hands
  • tingling or numbness of the hands or feet
  • dizziness or light-headedness on standing up from a sitting or lying position
  • unusual tiredness or weakness
  • muscle cramps or aches, joint pain
  • eye pain, vision changes
  • mood changes, feeling anxious or nervous
  • itching, yellowing of the skin and eyes, dark-coloured urine (signs of liver disease)
  • unusual movements, including trembling and shaking of the hands and fingers, twisting movements of the body, shuffling walk and stiffness of the arms and legs

The above list includes serious side effects and you may need medical attention.
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Emergency department at your nearest hospital:
  • shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, or other parts of the body; rash, itching or hives on the skin (symptoms of an allergic reaction)
  • fast or irregular heart beats
  • chest pain, alone or associated with exertion that lasts longer, is more severe or occurs more often
  • shortness of breath
  • severe upper stomach pain, often with nausea and vomiting

The above list includes very serious side effects and you may need urgent medical attention or hospitalisation.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may occur in some patients.

Storage and disposal

Storage


Keep your medicine in its pack until it is time to take it.
If you take your medicine out of its pack it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal


If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine left over.

Product description

What it looks like


5 mg tablets: white to off white, round, biconvex, uncoated tablets with ‘E21’ embossing on one side and break line on other side.
AUST R 307471
10 mg tablets: white to off white, round, biconvex, uncoated tablets with ‘10’ embossing on one side.
AUST R 307472
Blister packs of 10, 14, 28, 30, 50, 56 or 84 tablets. Not all pack sizes available.

Ingredients


Each tablet contains 5 mg or 10 mg as the active ingredient.
It also contains the following:
  • microcrystalline cellulose
  • calcium hydrogen phosphate dihydrate
  • sodium starch glycollate type A
  • colloidal anhydrous silica
  • magnesium stearate

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor


Arrotex Pharmaceutical Pty Ltd
15 – 17 Chapel Street
Cremorne, VIC 3121
www.arrotex.com.au
This leaflet was prepared in January 2024.

BRAND INFORMATION

Brand name

APX-Amlodipine (was Amlodipine APOTEX)

Active ingredient

Amlodipine

Schedule

S4

 

1 Name of Medicine

Amlodipine besilate.

2 Qualitative and Quantitative Composition

Each tablet contains amlodipine besilate, equivalent to 5 mg or 10 mg of amlodipine.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

APX-Amlodipine 5 mg tablet. White to off white, circular, biconvex, uncoated tablets debossed with 'E21' on one side and score line on other side.
APX-Amlodipine 10 mg tablet. White to off white, round, biconvex, uncoated tablets with '10' debossing on one side.

4 Clinical Particulars

4.9 Overdose

Symptoms. Available data suggest that overdose might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. Dysrhythmias may occur following overdose with any calcium antagonist. Hypotension and bradycardia are usually seen within 1 to 5 hours following overdose. Hypotension can persist for longer than 24 hours despite treatment. Cardiac rhythm disturbances have been noted to persist for up to 7 days. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Reports of intentional overdose include a patient who ingested 250 mg and was asymptomatic and was not hospitalised; another (120 mg) was hospitalised, underwent gastric lavage and remained normotensive; a third one (105 mg) was hospitalised and had hypotension (90/50 mmHg) which normalised following plasma expansion. Death resulted from a mixed overdose of 140 mg and 10 mefenamic acid capsules in a 15-year old girl, and from a mixed overdose of amlodipine 70 mg and an unknown quantity of oxazepam in a 63-year old woman. A case of accidental drug overdose has been documented in a 19 month old male who ingested 30 mg amlodipine (about 2 mg/kg). During the emergency room presentation, vital signs were stable with no evidence of hypotension, but a heart rate of 180 bpm.
Treatment. If massive overdose should occur, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine), should be considered with attention to circulating volume and urine output. Intravenous calcium may help to reverse the effects of calcium entry blockade.
Administration of activated charcoal to healthy volunteers immediately or up to 2 hours after ingestion of amlodipine 10 mg has been shown to significantly decrease amlodipine absorption. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube once the airway is protected. Ipecac-emesis is not recommended since haemodynamic instability and CNS depression may rapidly develop*.
Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. The carcinogenic potential of amlodipine has not been fully elucidated. Amlodipine did not induce any tumours when tested in rats at oral doses up to 2.5 mg/kg. This dose gave rise to plasma levels that are similar to those achieved clinically.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Amlodipine besilate is a dihydropyridine derivative. Amlodipine besilate is a white crystalline powder and is slightly soluble in water and sparingly soluble in ethanol.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAMBESI.gif Chemical Name: 3-ethyl 5-methyl (4RS)-2- [(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine -3,5-dicarboxylate benzenesulfonate.
Molecular Formula: C20H25ClN2O5.C6H6O3S. Molecular Weight: 567.1 (free base 408.9).
CAS number. 111470-99-6.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/APXAMLST.gif