Patient leaflet - Verapamil Hydrochloride BP tablets 40 mg

1. WHAT VERAPAMIL TABLETS ARE AND WHAT THEY ARE USED FOR

Verapamil Tablets are used to treat mild to moderate high blood pressure (hypertension) and chest pains caused by lack of oxygen getting to the heart (angina pectoris). They can also be used for treatment of a fast heart beat (tachycardia) and to treat and prevent certain types of abnormal heart beats.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VERAPAMIL TABLETS

Do not take Verapamil Tablets if you:

! Are allergic to verapamil hydrochloride or any

of the other ingredients of this medicine (listed in section 6)

! Have low blood pressure (hypotension) ! Have heart failure and are taking beta-

blockers

! Have heart failure, cardiogenic shock or

severe problems with the impulses and rhythms of the heart (second or third degree atrioventricular block, sino-atrial block or sick sinus syndrome) unless you have a pacemaker

! Have Wolff-Parkinson-White syndrome (rapid

heart rate sometimes associated with dizziness or faintness)

! Have recently suffered a heart attack ! Suffer from a slow heart rate (bradycardia) ! Are already taking a medicine containing

ivabradine for the treatment of certain heart diseases.

Do not drink grapefruit juice whilst taking verapamil as this may affect how your medicine works.

Warnings and precautions

Talk to your doctor or pharmacist before taking Verapamil Tablets if you:

! Have any liver problems as this may affect the

dose you require

! Have any kidney problems

! Have a condition where the nerve to muscle

transmission is affected e.g. myasthenia gravis, Lambert-Eaton syndrome or advanced Duchenne muscular dystrophy

! Have heart failure, have problems with the

impulses of the heart (first degree atrioventricular block) or suffer from a slow heart rate (bradycardia).

Your doctor will monitor your blood pressure regularly whilst you are taking this medicine.

Other medicines and Verapamil Tablets

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

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

! Beta-blockers used to treat high blood

pressure and heart conditions (these include atenolol, propranolol and metoprolol) ! Alpha blockers (particularly important if having

a beta blocker by injection) used to treat high blood pressure and heart conditions (these include prazosin and terazosin)

! Diuretics ('water pills'), antihypertensives (to

treat hypertension) or vasodilators (to open blood vessels)

! Medicines known as "statins" such as

atorvastatin, lovastatin and simvastatin, used to lower cholesterol levels

! Any other medicine for high blood pressure or

an abnormal heart beat (arrhythmia) such as quinidine, flecainide, digoxin and digitoxin ! Medicines used to treat depression (including

the herbal product St John's Wort), anxiety or psychosis. These may include imipramine, buspirone and lithium

! Medicines known as immunosuppressants

such as ciclosporin, sirolimus, everolimus and tacrolimus. These are used to prevent organ transplant rejection

! Glibenclamide, used to treat certain types of

diabetes

! Aspirin, a non-steroidal anti-inflammatory

painkiller (NSAID) used to relieve pain and reduce fever

! Almotriptan, used to treat migraine ! Midazolam, used as a sedative or anaesthetic ! Theophylline, used to treat asthma ! Doxorubicin, an anti-cancer medicine ! Cimetidine, used to treat indigestion or

stomach ulcers

! Carbamazepine, phenytoin or phenobarbital

(phenobarbitone). These medicines are used as anti-convulsants to treat epilepsy ! Rifampicin, used to treat tuberculosis and

other types of infection

! Ritonavir, used to treat HIV

! Erythromycin, clarithromycin and

telithromycin, used to treat certain types of infection

! Colchicine or sulfinpyrazone, used to treat

gout

! Dabigatran (medicine to prevent the formation

of blood clots)

! Ivabradine (for heart disease).

! Metformin (to treat diabetes) as verapamil

may decrease the glucose-lowering effect of metformin

If you are going to have surgery, including dental, tell your doctor or dentist you are taking this medicine.

Verapamil Tablets with food, drink and alcohol

Do not eat or drink products containing grapefruit juice while taking this medicine. This is because drinking grapefruit juice can increase the effects of verapamil and should be avoided while taking this medicine.

Limit the amount of alcohol you drink while taking this medicine. This is because drinking alcohol while taking this medicine will increase the chance of having a problem with your liver. Talk to your doctor or pharmacist about the amount of alcohol you can drink.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant, planning to have a baby or are breast-feeding, ask your doctor or pharmacist before taking this medicine.

Driving and using machines

These tablets may cause dizziness or fatigue, particularly when you first start taking it and when changing over from another medicine. Make sure you are not affected before you drive or operate machinery, especially if taken with alcohol.

Verapamil Tablets contain lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE VERAPAMIL TABLETS

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Taking this medicine

! Take this medicine by mouth

! Swallow the tablets whole. Do not crush or

chew your tablets

! If you feel the effect of your medicine is too

weak or too strong do not change the dose yourself, but ask your doctor.

The usual dose for:

Angina is 120mg, three times a day.

Tachycardia (increased heart rate)

! For an adult is 40mg to 120mg, three times a

day

! For children 2 years and above: 40mg to

120mg, two to three times daily according to age.

Hypertension (high blood pressure) ! Initially 120mg twice a day increasing to

160mg twice a day. In some cases up to a maximum of 480mg a day can be taken in divided doses.

! For children up to 10mg/kg/day in divided

doses, as directed by your doctor.

Elderly:

The prescribed dose may be lower than the usual dose.

Patients with impaired liver or kidney function or cardiac conduction problems may be prescribed a reduced dose.

If you take more Verapamil Tablets than you should

This medicine is to be taken at regular intervals, as determined by the physician. If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you. Overdose can lead to low blood pressure and in rare cases heart failure.

If you forget to take Verapamil Tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember. If it is nearly time for the next dose, skip the missed dose and take the next dose at the right time. If you have trouble remembering to take tablets, tell your doctor or pharmacist.

If you stop taking Verapamil Tablets

Talk to your doctor before you stop taking the tablets and follow their advice. Keep taking your tablets until your doctor tells you to stop. Do not stop taking your tablets just because you feel better. If you stop taking this medicine your symptoms may come back.

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 cause side effects, although not everyone gets them.

If you experience any of the following then STOP taking the medicine and contact a doctor immediately

! Allergic reaction: itching, rashes, difficulty

breathing and swelling of the face, lips or tongue

! Palpitations, chest pains for the first time or

chest pains becoming more frequent. ! Stevens-Johnson syndrome: symptoms

include fever and flu-like symptoms, rash, skin blisters, peeling skin

! Liver problems which can be indicated by

yellowing of the skin or eyes and detected by blood tests done by your doctor.

Tell your doctor if you notice any of the following side effects, they get worse or you notice any other effects not listed:

Nervous system - headaches, dizziness, 'pins and needles', involuntary shaking or spasm Ears - spinning sensation, 'ringing in the ears' Heart /blood vessels - fast, slow or irregular heartbeat, low blood pressure, flushing/reddening of the skin, swelling of the ankles, hands or feet Stomach - constipation, feeling or being sick, pain or discomfort in the stomach, swelling of the gums

Skin - hair loss, skin rash or itching, discolouring, tingling or prickling feeling, blisters, ulcers, numbness, burning pain associated with increased skin temperature

Muscle - muscle weakness, tremor, aches, pains in the joints and/or muscles

Reproductive system - problems getting and maintaining an erection, enlarged breasts in men (reversible when treatment is stopped), milky secretion from the breasts

Other: tiredness, liver problems which can be indicated by yellowing of the skin or eyes and detected by blood tests done by your doctor, increased levels of prolactin in the blood.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE VERAPAMIL TABLETS

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Store below 25°C in a dry place.

Do not use this medicine if you notice any visible signs of deterioration.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Verapamil Tablets contain:

Each Verapamil Hydrochloride 40mg Tablet contains 40mg of the active ingredient verapamil Hydrochloride.

Each Verapamil Hydrochloride 80mg Tablet contains 80mg of the active ingredient verapamil Hydrochloride.

Each Verapamil Hydrochloride 120mg Tablet contains 120mg of the active ingredient verapamil Hydrochloride.

The other ingredients are: microcrystalline cellulose, lactose monohydrate (see section 2), maize starch, colloidal silicon dioxide, magnesium stearate, hydroxypropyl

methylcellulose (E464), quinoline yellow (E104) and titanium dioxide (E171).

What Verapamil Tablets look like and contents of the pack

Verapamil Hydrochloride 40mg Tablets are yellow, round, biconvex tablets plain on both the sides with an approximate diameter of 7 mm. Verapamil Hydrochloride 80mg Tablets are yellow, round, biconvex tablets plain on both the sides with an approximate diameter of 9 mm. Verapamil Hydrochloride 120mg Tablets are yellow, round, biconvex tablets plain on both the sides with an approximate diameter of 10 mm. Verapamil Tablets are available in blister packs containing 28, 30, 56, 60, 84, 90, 100, 112 or 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate

Riverside Way, Dartford, DA1 5BS,

United Kingdom

Manufacturer

Ennogen Pharma Ltd