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PACKAGE LEAFLET: INFORMATION FOR THE USER

VERAPAMIL 40 mg, 80 mg & 120 mg TABLETS

VERAPAMIL HYDROCHLORIDE

THIS LEAFLET CONTAINS

1.    What Verapamil is for

2.    Before you take Verapamil

3.    How to take Verapamil

4.    Possible side effects

5.    How to store Verapamil

6.    Further information

1. WHAT VERAPAMIL IS FOR

Verapamil belongs to a group of medicines called calcium channel blockers. The heart muscle and the muscle in your blood vessel walls need calcium to contract and tighten.

Verapamil stops calcium from getting into these muscles. This

•    relaxes your heart and blood vessels

•    makes your heart pump out less blood every time it beats

•    slows down your heart rate (pulse).

Verapamil can be used to:

•    treat high blood pressure (hypertension). It may be prescribed on its own or in combination with other heart medicines

•    treat and prevent chest pain (angina)

•    treat and prevent heart rhythm problems such as heart flutter (supraventricular tachycardia).

If you are not sure why you have been prescribed this medicine then please ask your doctor.

2. BEFORE YOU TAKE VERAPAMIL

Do not take Verapamil and tell your doctor if you:

•    are allergic to Verapamil or any other ingredients in the tablets (listed in section 6 of this leaflet). The signs of an allergic reaction include a rash, itching or shortness of breath

•    have second or third-degree atrioventricular block or sino-atrial block. This is a disorder where parts of your heart may beat at the wrong time causing it not to pump blood around the body very well

•    have a heart beat disorder, such as sick sinus syndrome, Wolff-Parkinson-White syndrome or Lown-Ganong-Levine syndrome

•    have a problem where your heart beats very slowly (severe bradycardia)

•    have low blood pressure (hypotension)

•    have an inherited blood disorder known as porphyria.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

You will not be given Verapamil if you:

•    have a sudden and rapid fall in blood pressure (cardiogenic shock)

•    have heart failure that is not being treated

•    have a sudden heart attack, particularly if you have a slow heart beat, low blood pressure or a type of heart failure called 'left ventricular failure'.

You will not be given this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Take special care with Verapamil

Tell your doctor before you take this medicine if you:

•    have liver or kidney problems

•    have first degree atrioventricular block. This is a disorder where parts of your heart may beat at the wrong time causing it not to pump blood around the body very well

•    are taking other medicines to treat heart problems, such as Digoxin or beta blockers (e.g. Atenolol or Propranolol)

•    are pregnant or breast-feeding (see 'Pregnancy and breast-feeding' section)

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Having tests and operations while you are taking Verapamil

•    your doctor may monitor your blood pressure regularly

•    if you are going to be given an anaesthetic, tell the doctor or dentist that you are taking Verapamil.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines bought without a prescription. This is because Verapamil can affect the way some medicines work. Also some medicines can affect the way Verapamil works.

In particular, tell your doctor or pharmacist if you are taking any of the following:

•    Medicines to treat heart failure, such as Digoxin or Eplerenone

•    Medicines used to lower blood pressure and treat abnormal heart rhythms, such as beta blockers (e.g. Atenolol or Propranolol), Amiodarone, Disopyramide, Flecainide or Quinidine

•    Ivabradine to treat cheat pain

•    Simvastatin used to lower cholesterol levels

•    Medicines to treat epilepsy, such as Carbamazepine, Phenytoin, Phenobarbital or Primidone

•    Midazolam used to make you sleepy

•    Lithium to treat mental health problems

•    Medicines to treat depression, such as Amitriptyline or Imipramine

•    Buspirone to treat anxiety

•    Theophylline to treat asthma

•    Rifampicin to treat TB (tuberculosis)

•    Atazanavir or Ritonavir to treat HIV (Human Immunodeficiency Virus)

•    Clarithromycin or Erythromycin to treat bacterial infections

•    Cimetidine to treat stomach ulcers

•    Ciclosporin, Sirolimus or Tacrolimus used to stop the rejection of organs after transplants

•    Injected Dantrolene to treat severe muscle spasms

•    Muscle relaxants, such as Atracurium or Suxamethonium

•    Darifenacin to treat urinary problems

•    Dutasteride to treat an enlarged prostate gland.

Taking Verapamil with food and drink

•    do not drink grapefruit juice whilst taking Verapamil. This is because grapefruit juice may change the blood levels of your medicine

•    you should monitor the amount of alcohol you drink whilst taking Verapamil. This is because Verapamil can affect the way the body gets rid of alcohol. This means that you may not have to drink as much for your blood alcohol levels to be above the legal limit to drive. It will also take you longer to sober up.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, planning to become pregnant or are breast-feeding.

•    you must only take this medicine in the first 3 months of pregnancy (1st trimester) if your doctor thinks it is essential

•    you must only take this medicine if you are breast-feeding if your doctor thinks it is necessary.

Driving and using machines

When starting a new medicine, you may find that your ability to drive a car or use machinery can be impaired. You should take care when driving or using machines until you know how you react to this medicine.

Important information about some of the ingredients of Verapamil

Verapamil tablets contain lactose (a type of sugar). If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine.

Verapamil tablets also contain sunset yellow (E110), which may cause allergic reactions.

3. HOW TO TAKE VERAPAMIL

Always take Verapamil tablets exactly as your doctor or pharmacist has told you. Take this medicine by mouth.

Adults

The usual dose is:

For high blood pressure: 120 mg twice a day. Your doctor may increase this to a maximum of 160 mg two or three times a day.

For angina: 120 mg three times a day. Your doctor may lower this dose.

For heart rhythm disorders: 40 mg to 120 mg

three times a day.

Elderly

The dose will be the same as that for adults. If you have a liver or kidney problem, your doctor may lower your dose.

Children

The doctor will decide if this medicine is suitable for your child, depending on your child's condition and age.

The usual dose for children is:

Up to 2 years of age: 20 mg two or three times a day.

2 years of age and above: 40 mg to 120 mg two

or three times a day.

If you take more Verapamil than you should

If you take more Verapamil than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.

If you forget to take Verapamil

If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Verapamil

Do not stop taking this medicine without talking to your doctor first. If you stop taking this medicine it may make your condition worse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Verapamil can cause side effects, although not everybody gets them.

If you have any of the following side effects, STOP TAKING this medicine and see a doctor or go to a hospital straight away:

•    an allergic reaction which may cause an itchy skin rash, flaking skin, red and raised lumps (hives), blistering of your skin, mouth, eyes or genitals, sudden wheezing, fluttering or tightness of your chest or collapse, swelling of your face, lips, tongue or throat or difficulty in breathing or swallowing

•    heart problems such as low blood pressure (hypotension), slow heart beats, unusual heart beats, heart attack or heart failure. This is more likely if you are taking high doses or you already have damage to your heart.

If you get any of the following side effects, see your doctor as soon as possible:

•    swelling of your ankles

•    swelling of your blood vessels which may show as pain in the fingers and toes

•    numbness or tingling

•    muscle or joint pain.

Tell your doctor if you get any of these side effects:

•    breast development in older men

•    constipation

•    flushing of your face

•    headaches, feeling dizzy or tired

•    feeling sick (nausea) or being sick (vomiting)

•    swollen and overgrown gums.

This medicine may also cause an increase in levels of a hormone called prolactin. This will only be detected through tests performed by your doctor.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE VERAPAMIL

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package to protect from light or store in the original container and keep the container tightly closed.

Do not use the tablets after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Verapamil tablets contain

The active substance (the ingredient that makes the tablets work) is verapamil hydrochloride.

The other ingredients in the tablets are maize starch, lactose, gelatin, magnesium stearate, colloidal anhydrous silica, talc, titanium dioxide (E171), quinoline yellow (E104), sunset yellow (E110), hydroxypropyl cellulose, hydroxypropyl methylcellulose, ethylcellulose and diethyl phthalate.

What Verapamil tablets look like and contents of the pack

Verapamil tablets are round, pale yellow, film coated tablets with a marking engraved on one side. The 40 mg tablets are engraved with MP68, the 80 mg tablets are engraved with MP69 and the 120 mg tablets are engraved with MP70.

All three strengths of Verapamil tablets come in blister packs of 28 tablets and in containers of 84, 100 and 500 tablets. Verapamil 120 mg tablets also come in containers of 28 and 56 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Metwest Pharmaceuticals Limited,

15 Runnelfield, Harrow on the Hill,

Middlesex HA1 3NY

Manufacturer

DDSA Pharmaceuticals Limited,

310 Old Brompton Road,

London SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 10/2009

VRP0068&0069&0070/040&080&120F/LEA004