Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Verapamil Mylan.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Verapamil Mylan against the benefits expected for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What Verapamil Mylan is used for

Verapamil Mylan tablets are used to treat:

• high blood pressure, also called hypertension
• angina (chest pain)
• some types of arrhythmias (irregular heartbeats).

Verapamil Mylan belongs to a group of medicines called calcium antagonists or calcium channel blockers. These medicines work by opening up blood vessels, causing blood pressure to fall and letting more blood and oxygen reach the heart. Calcium channel blockers also help control an irregular heartbeat.

Verapamil Mylan does not change the amount of calcium in your blood or bones. Calcium in your diet or in calcium supplements will not interfere with the way Verapamil Mylan works.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor's prescription.

Before you take Verapamil Mylan

When you must not take it

Do not take Verapamil Mylan if you have an allergy to:

• medicines containing verapamil hydrochloride
• 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 or other parts of the body
• Rash, itching or hives on the skin

Do not take this medicine if you have:

• low blood pressure (hypotension)
• certain other heart conditions (such as heart failure, a very slow heart rate, some irregular heartbeats or disease of the heart muscle)
• are taking any of the following medicines or medications containing these ingredients
  - ivabradine
  - dabigatran (in certain situations)

Do not take this medicine after the expiry date (EXP) printed on the bottle or if the bottle 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, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant. Verapamil Mylan may harm your developing baby. Your doctor will discuss the risks and benefits of taking Verapamil Mylan during pregnancy.

Tell your doctor if you are breastfeeding or wish to breastfeed. Verapamil Mylan passes into breast milk. Your doctor will discuss the risks and benefits of taking Verapamil Mylan when breastfeeding.

Tell your doctor if you have, or have had, any of the following medical conditions:

• any other heart problem
• blood vessel (circulatory) disease or a stroke
• liver problems
• kidney problems
• muscle conditions such as myasthenia gravis, Lambert-Eaton syndrome, and Duchenne's muscular dystrophy.

Your doctor may want to take special care if you have any of these conditions.

Tell your doctor if you plan to have surgery.

If you have not told your doctor about any of the above, tell him/her before you start taking Verapamil Mylan.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and Verapamil Mylan may interfere with each other. These include:

• beta blockers (eg. atenolol, metoprolol, propranolol)
• ivabradine
• fluid tablets, also called diuretics
• any other medicines used to control an irregular heartbeat e.g. digoxin, quinidine, flecainide, amiodarone, disopyramide
• medicines used to treat high blood pressure (especially prazosin or terazosin)
• medicines used to lower cholesterol, such as atorvastatin or simvastatin
• medicines used to treat psychological problems, such as imipramine, buspirone, midazolam or lithium
• medicines used to treat epilepsy or seizures, such as phenytoin, carbamazepine and phenobarbitone
• medicines used to treat or prevent organ transplant rejection, such as cyclosporine, everolimus, sirolimus and tacrolimus
• medicines used to treat infections or tuberculosis, such as erythromycin, clarithromycin, telithromycin or rifampicin
• medicines used in the treatment of Human Immunodeficiency Virus (HIV), such as ritonavir
• medicines used to treat or prevent gout, such as colchicine or sulfinpyrazone
• medicines used in surgical procedures such as general anaesthetics used for inducing sleep, muscle relaxants
• theophylline, a medicine used to treat asthma
• doxorubicin, a medicine used to treat certain cancers
• cimetidine, a medicine commonly used to treat stomach ulcers and reflux
• glibenclamide, a medicine used to treat diabetes
• dabigatran, aspirin, blood thinning medicine also used for pain relief

Avoid alcohol while using Verapamil Mylan. You may experience greater blood pressure lowering effects than usual.

Avoid grapefruit juice, as this may increase the blood levels of verapamil.

These medicines may be affected by Verapamil Mylan 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 and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take Verapamil Mylan

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the bottle, ask your doctor or pharmacist.

How much to take

The dose varies from person to person.

Your doctor will tell you how many tablets you need to take each day and when to take them. This depends on the condition being treated and whether or not you are taking any other medicines.

People with liver problems may need smaller doses.

How to take it

Swallow the tablets with a glass of water.

Verapamil Mylan tablets can be divided in half along the breakline, if your doctor has prescribed half a tablet.

When to take it

Verapamil Mylan tablets are usually taken two or three times a day, space the tablets evenly apart throughout the 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 before or after food.

How long to take it

Verapamil Mylan is usually taken as long-term treatment.

Continue taking your medicine for as long as your doctor tells you to.

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.

If you forget to take it

If it is almost time for 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 the dose you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

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 the nearest hospital, if you think you or anyone else may have taken too much Verapamil Mylan. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much Verapamil Mylan, you may develop a slow heartbeat, experience chest pain, feel very faint or collapse.

While you are taking Verapamil Mylan

Things you must do

If you become pregnant while taking Verapamil Mylan, tell your doctor immediately.

Tell your doctor if you continue to have chest pain or if it becomes more frequent while you are taking Verapamil Mylan.

Before starting any new medicine, tell your doctor or pharmacist that you are taking Verapamil Mylan.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Verapamil Mylan.

If you plan to have surgery, including dental surgery, tell your surgeon, anaesthetist or dentist that you are taking Verapamil Mylan.

Visit your doctor regularly so they can check on your progress. Your doctor may ask you to have blood tests to check your liver from time to time.

Things you must not do

Do not eat grapefruit or drink grapefruit juice while you are being treated with Verapamil Mylan. Grapefruit can affect Verapamil Mylan levels in the body. This may increase the chance of getting unwanted side effects.

Do not stop taking Verapamil Mylan, or change the dose, without checking with your doctor.

Do not let yourself run out of Verapamil Mylan over weekends or holidays.

Do not use Verapamil Mylan to treat any other conditions unless your doctor tells you to.

Do not give this medicine to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful getting up from a sitting or lying position. Dizziness, lightheadedness or fainting may occur, especially when you get up quickly. Getting up slowly may help.

Make sure you know how Verapamil Mylan affects you before you drive a car, operate machinery, or do anything else that could be dangerous. Verapamil Mylan may cause tiredness, dizziness or lightheadedness in some people, especially when they first start taking the medicine or the dose is changed.

Be careful drinking alcohol while taking Verapamil Mylan. Combining alcohol with Verapamil Mylan may make you more drowsy, dizzy or lightheaded. Your doctor may suggest you avoid alcohol while you are taking Verapamil Mylan.

Lifestyle measures that help reduce heart disease risk

By following these simple measures, you can further reduce the risk from heart disease.

• Quit smoking and avoid second-hand smoke.
• Limit alcohol intake.
• Enjoy healthy eating by:
  - eating plenty of vegetables and fruit;
  - reducing your saturated fat intake (eat less fatty meats, full fat dairy products, butter, coconut and palm oils, most take-away foods, commercially-baked products).
• Be active. Progress, over time, to at least 30 minutes of moderate-intensity physical activity on 5 or more days each week. Can be accumulated in shorter bouts of 10 minutes duration. If you have been prescribed anti-angina medicine, carry it with you when being physically active.
• Maintain a healthy weight.
• Discuss your lifestyle and lifestyle plans with your doctor.
• For more information and tools to improve your heart health, call Heartline, the Heart Foundation's national telephone information service, on 1300 36 27 87 (local call cost).

Know warning signs of heart attack and what to do:

• Tightness, fullness, pressure, squeezing, heaviness or pain in your chest, neck, jaw, throat, shoulders, arms or back.
• You may also have difficulty breathing, or have a cold sweat or feel dizzy or light headed or feel like vomiting (or actually vomit).
• If you have heart attack warning signs that are severe, get worse or last for 10 minutes even if they are mild, call triple zero (000). Every minute counts.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Verapamil Mylan.

Verapamil Mylan helps most people and is usually well tolerated, but may have unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

If you are over 65 years of age, you may have an increased chance of getting side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

• constipation
• dizziness or lightheadedness
• feeling sick (nausea)
• upset stomach
• headache
• tiredness
• flushing.

The above list includes the milder and more common side effects of Verapamil Mylan.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

• chest pain, fainting, collapse
• slow, fast, or irregular heart beat
• shortness of breath (sometimes with tiredness, weakness and reduced ability to exercise), which may occur together with swelling of the feet or legs due to fluid build up
• fever, upper stomach pain, feeling generally unwell
• severe blisters, skin rash, itching or flaking skin.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice anything that is making you feel unwell.

This is not a complete list of all possible side effects.

Other side effects not listed above may also occur in some people.

After taking Verapamil Mylan

Storage

Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 30°C.

Do not store Verapamil Mylan 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 it 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 that are left over.

Product description

What it looks like

Verapamil Mylan is available as:

• Verapamil Mylan 40 -yellow, round, scored, film-coated tablet marked "VL/40" on one side and "G" on the other, bottles of 100 tablets
• Verapamil Mylan 80 - yellow-orange, round, scored, film-coated tablet marked "VL/80" on one side and "G" on the other, bottles of 100 tablets

Ingredients

The active ingredient in Verapamil Mylan is verapamil hydrochloride.

Each tablet of:

• Verapamil Mylan 40 contains 40 mg of verapamil hydrochloride
• Verapamil Mylan 80 contains 80 mg of verapamil hydrochloride

It also contains the following inactive ingredients:

• lactose anhydrous
• microcrystalline cellulose
• pregelatinised maize starch
• sodium starch glycollate
• purified talc
• magnesium stearate
• hypromellose
• macrogol 400
• titanium dioxide CI77891 (E171)
• quinoline yellow CI47005 (E104)
• sunset yellow FCF CI15985 (E110)
• indigo carmine CI73015 (E132).

Verapamil Mylan tablets are gluten free.

Supplier

Verapamil Mylan is supplied by:

Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.mylan.com.au

Australian registration numbers:

Verapamil Mylan 40 - AUST R 80443

Verapamil Mylan 80 - AUST R 80444

This leaflet was prepared in June 2019.

Verapamil Mylan_cmi\Jun19/00

Published by MIMS January 2020

1 Name of Medicine

Verapamil hydrochloride.

6.7 Physicochemical Properties

Molecular formula: C₂₇H₃₈N₂O₄.HCl. Molecular weight: 491.1.

Chemical structure.

CAS number.

2 Qualitative and Quantitative Composition

Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist).
Each tablet contains 40 mg or 80 mg of verapamil hydrochloride as the active ingredient.

Excipients with known effect.

3 Pharmaceutical Form

Verapamil hydrochloride is a white or almost white, odourless, crystalline powder.
Verapamil Mylan 40 mg is available as a pale yellow, film coated tablet, marked "VL/40" on one side, "G" on the other.
Verapamil Mylan 80 mg tablet is available as a orange/yellow, film coated tablet, marked "VL/80" on one side, "G" on the other.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Hypertension.

Angina pectoris.

Other pharmacological actions.

Clinical trials.

Hypotension.

5.2 Pharmacokinetic Properties

Verapamil hydrochloride is rapidly and almost completely absorbed from the gastrointestinal tract. The overall oral bioavailability ranges from 22 to 35% due to a substantial hepatic first-pass effect. Peak plasma concentrations are reached between one and two hours after oral administration. Chronic oral administration of 120 mg of verapamil every 6 hours resulted in plasma levels of verapamil ranging from 125 to 400 nanogram/mL with higher values reported occasionally. A nonlinear correlation between the verapamil dose administered and verapamil plasma levels does exist.
In early dose titration with verapamil, a relationship exists between verapamil plasma concentrations and the prolongation of the PR interval. However, during chronic administration this relationship may disappear. The mean elimination half-life in single dose studies ranged from 2.8 to 7.4 hours. In these same studies, after repetitive dosing the half-life increased to a range from 4.5 to 12.0 hours (after less than ten consecutive doses given 6 hours apart). Half-life of verapamil may increase during titration.
Aging may affect the pharmacokinetics of verapamil. Elimination half-life may be prolonged in the elderly.
In healthy subjects, orally administered verapamil undergoes extensive metabolism in the liver. Twelve metabolites have been identified in plasma. Norverapamil can reach steady-state plasma concentrations approximately equal to those of verapamil itself. The cardiovascular activity of norverapamil appears to be approximately 20% that of verapamil. Approximately 70% of an administered dose is excreted as metabolites in the urine and 16% or more in the faeces within five days. About 3% to 4% is excreted in the urine as unchanged drug. Approximately 90% is bound to plasma proteins.
In patients with hepatic insufficiency, metabolism of immediate release verapamil is delayed and elimination half-life prolonged up to 14 to 16 hours (see Section 4.4 Special Warnings and Precautions for Use); the volume of distribution is increased and plasma clearance reduced to about 30% of normal. Verapamil clearance values suggest that patients with liver dysfunction may attain therapeutic verapamil plasma concentrations with one-third of the oral daily dose required for patients with normal liver function.
Impaired renal function has no effect on verapamil hydrochloride pharmacokinetics in patients with endstage renal failure and subjects with healthy kidneys.
After four weeks of oral dosing (120 mg four times daily), verapamil and norverapamil levels were noted in the cerebrospinal fluid. Estimated partition coefficient of 0.06 for verapamil and 0.04 for norverapamil.

Haemodynamics and myocardial metabolism.

Pulmonary function.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

Animal pharmacology and/or animal toxicology.

4 Clinical Particulars

4.1 Therapeutic Indications

Hypertension; angina of effort; angina at rest; vasospastic angina (including Prinzmetal's variant angina); tachyarrhythmias including paroxysmal supraventricular tachycardia; atrial fibrillation and atrial flutter with rapid ventricular response.

4.3 Contraindications

Verapamil HCl is contraindicated in the following.
Severe left ventricular dysfunction (see Section 4.4 Special Warnings and Precautions for Use).
Hypotension (systolic pressure less than 90 mmHg) or cardiogenic shock.
Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker).
Second or third degree A-V block (except in patients with a functioning artificial ventricular pacemaker).
Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g. Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) (see Section 4.4 Special Warnings and Precautions for Use). These patients are at risk to develop ventricular tachyarrhythmia including ventricular fibrillation if verapamil hydrochloride is administered.
Heart failure with reduced ejection fraction of less than 35%, and/or pulmonary wedge pressure above 20 mmHg.
Patients concomitantly administered ivabradine (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Simultaneous initiation of treatment with dabigatran etexilate and oral verapamil (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Treatment initiation with oral verapamil in patients following major orthopaedic surgery who are already treated with dabigatran etexilate (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Patients with known hypersensitivity to verapamil hydrochloride or any of the inactive ingredients.

4.4 Special Warnings and Precautions for Use

Heart failure.

Acute myocardial infarction.

Hypotension.

Elevated liver enzymes.

Accessory bypass tract (Wolff-Parkinson-White or Lown-Ganong-Levine).

Atrioventricular block.

Patients with hypertrophic cardiomyopathy (IHSS).

Use in patients with impaired neuromuscular transmission.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

In vitro metabolic studies indicate that verapamil hydrochloride is metabolised by cytochrome P450 CYP3A4, CYP1A2, CYP2C8, CYP2C9 and CYP2C18. Verapamil has been shown to be an inhibitor of CYP3A4 enzymes and P-glycoprotein (P-gp). Clinically significant interactions have been reported with inhibitors of CYP3A4 causing elevation of plasma levels of verapamil while inducers of CYP3A4 have caused a lowering of plasma levels of verapamil, therefore, patients should be monitored for drug interactions.

Beta-blockers.

Ivabradine.

Digitalis.

Antihypertensive agents.

Antiarrhythmic agents.

Nitrates.

Cimetidine.

Lithium.

Prazosin, terazosin.

HIV antiviral agents.

Carbamazepine.

Erythromycin, clarithromycin and telithromycin.

Rifampicin.

Phenobarbital.

Cyclosporin.

Everolimus, sirolimus and tacrolimus.

Buspirone.

Midazolam.

Theophylline.

Phenytoin.

Alcohol.

Inhalation anaesthetics.

Neuromuscular blocking agents.

Grapefruit juice.

HMG-CoA reductase inhibitors.

Sulfinpyrazone.

Aspirin.

Dabigatran.

Doxorubicin.

Colchicine.

Imipramine.

Glibenclamide.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.8 Adverse Effects (Undesirable Effects)

Verapamil is usually well tolerated.
Serious adverse reactions are uncommon when verapamil therapy is initiated with upward dose titration within the recommended single and total daily dose. See Section 4.4 Special Warnings and Precautions for Use for discussion of heart failure, hypotension, elevated liver enzymes, A-V block and rapid ventricular response. See Section 5.1 Pharmacodynamic Properties, Clinical trials.
The following reactions, reported in 1% or less of patients, occurred under verapamil HCl administration in general (all formulations) and most of them under conditions (open trials, marketing experience) where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship.

Cardiovascular.

Digestive system.

Haemic and lymphatic.

Nervous system.

Skin.

Special senses.

Ear and labyrinth disorders.

Urogenital.

Treatment of acute cardiovascular adverse reactions.

Adverse effects from post-marketing surveillance.

Reporting suspected adverse effects.

4.2 Dose and Method of Administration

The individual dose and frequency of dosing should be determined in accordance with the indication and individual patient response.

Adults.

Usual maintenance dose.

Children.

Elderly, impaired renal function.

Impaired hepatic function.

4.7 Effects on Ability to Drive and Use Machines

Due to its antihypertensive effect, depending on the individual response, verapamil hydrochloride may affect the ability to react to the point of impairing the ability to drive a vehicle, operate machinery or work under hazardous conditions. This applies all the more at the start of treatment, when the dose is raised, when switching from another drug and in conjunction with alcohol. Verapamil may increase the blood levels of alcohol and slow its elimination. Therefore, the effects of alcohol may be exaggerated.

4.9 Overdose

Symptoms.

Treatment.

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each Verapamil Mylan tablet contains verapamil hydrochloride 40 mg or 80 mg as the active ingredient. The tablets also contain the following inactive ingredients: lactose, microcrystalline cellulose, pregelatinised maize starch, sodium starch glycollate, purified talc and magnesium stearate. Verapamil Mylan 40 also contains Opadry Yellow OY-LS-32814 and Verapamil Mylan 80 contains Opadry Orange OY-LS-33113.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.
This medicinal product does not require any special storage conditions.

6.5 Nature and Contents of Container

Container type: HDPE Bottle with child-resistant PP cap.
Pack sizes: available in packs of 100's bottles* of 30's, 90's and 100's*.
*Marketed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

Summary Table of Changes