9.0 pt

Package leaflet: Information for the user

UNIVER® 120 mg, 180 mg and 240 mg Prolonged Release Hard Capsules

(Verapamil hydrochloride)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What UNIVER is and what it is used for

2.    What you need to know before you use UNIVER

3.    How to use UNIVER

4.    Possible side effects

5.    How to store UNIVER

6.    Contents of the pack and other information 1. What UNIVER is and what it is used for

The name of this medicine is UNIVER prolonged release hard capsules and it comes in three strengths (120 mg, 180 mg and 240 mg).

The active ingredient in them is verapamil hydrochloride which belongs to a group of medicines called calcium channel blockers.

UNIVER is used to treat high blood pressure (hypertension) and chest pains caused by lack of oxygen getting to the heart (angina pectoris).

_2. What you need to know before you use UNIVER

Do not take UNIVER:

if you are sensitive (allergic) to verapamil hydrochloride or any of the other ingredients of this medicine (listed in section 6). if you have had a heart attack which has been followed by a slow heart rate, low blood pressure or breathlessness. if you have a slow heart rate which is not controlled by a pacemaker. if you have low blood pressure.

if you suffer from sick sinus syndrome (causing a slow heart rate). if you have a weak heart (causing breathlessness and tiredness).

if you suffer with Lown-Ganong-Levine or Wolff-Parkinson-White syndrome (causing palpitations). if you suffer from porphyria (a rare inherited disease affecting the blood). if you have been given a muscle relaxant called dantrolene by injection. if you have been given a type of medicine called a Beta-blocker by injection. if you are already taking a medicine containing ivabradine for the treatment of certain heart disease.

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

This medicine is not suitable for anyone under the age of 18 years old.

Talk to your doctor before taking this product if any of the above apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before using UNIVER

•    if you are pregnant or breast-feeding.

•    if you have any liver problems.

•    if you have any kidney problems.

•    if you have low blood pressure.

•    if you have any heart conditions.

•    if you have myasthenia gravis, Lambert-Eaton syndrome or Duchenne muscular dystrophy (nervous conditions which cause muscle weakness).

•    if you are taking medicine for high blood cholesterol (a “statin”, such as simvastatin or atorvastatin).

Children and adolescents

There are no data on the use of verapamil prolonged release tablets in children and adolescents.

Other medicines and UNIVER

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

•    Beta-blockers used to treat high blood pressure and heart conditions (these include atenolol, propanolol and metoprolol).

•    Alpha blockers used to treat high blood pressure and heart conditions (these include prazosin and terazosin).

•    Diuretics (also called “water pills”).

•    Medicines known as “statins” such as atorvastatin, simvastatin used to lower cholesterol levels.

• Any other medicine for high blood pressure or an abnormal heart beat (arrhythmia) such as quinidine, disopyramide, 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 ciclosporing, 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 phenobartbital (phenobarbitone). These medicines are used as anti-convulsants.

•    Rifampicin, used to treat tuberculosis and other types of infection.

•    Ritonavir, used to treat HIV.

•    Erythromycin, telithromycin, clarithromycin and ketoconazole, used to treat certain types of infection.

•    Colchicine or sulfinpyrazone, used to treat gout.

•    dantrolene, used in multiple sclerosis to relax muscles.

Tell your surgeon or dentist that you are taking UNIVER if surgery is planned as it may affect the anaesthetic used.

TEXT SIZE

The SMALLEST BODY text on this A/W is at:

9.0 pt

UNIVER with food, drink and alcohol

You can drink alcohol while taking this medicine, however, the effects of alcohol may be increased when taken together with UNIVER.

If you are concerned about how much alcohol you can drink while you are taking this medicine discuss this with your doctor.

Grapefruit juice can increase the effects of UNIVER and should be avoided whilst taking this medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant, think you might be pregnant, or are breast-feeding you should ask you doctor or pharmacist for advice before taking UNIVER.

Driving and using machines

UNIVER may cause dizziness or fatigue, particularly when you first start taking it. If you are affected you should not drive or operate machinery.

UNIVER contains sucrose

UNIVER contains sucrose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking UNIVER.

3. How to use UNIVER

Always take UNIVER exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Mild to moderate high blood pressure

Initially the dose will be 120 mg once a day, but this may be increased to 240 mg once a day or to a maximum of 480 mg once a day.

Angina

The usual dose is 360 mg once a day. This may be increased to 480 mg once a day.

The capsules should be swallowed whole with water (not chewed or sucked).

You may be prescribed a different dose if you have liver or kidney problems or are elderly.

If you take more UNIVER than you should

If you take too much UNIVER you should go to the nearest hospital casualty department immediately. Take the packet and this leaflet with you so that the doctor will know what you have taken.

If you forget to take UNIVER

If you forget to take your dose, take it as soon as you remember. If it is almost time for the next dose (up to 8 hours before), do not take the missed dose but take your next dose at your normal time. Do not take a double dose.

4.    Possible side effects

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

Stop taking this medicine and tell your doctor immediately if you have difficulty breathing or your mouth or throat begins to swell or if you start suffering from a severe rash, itching or other skin reactions, as these may be signs of a serious allergic reaction.

Tell your doctor immediately if you experience any of the following side effects:

•    Yellowing of the skin or eyes, a fever or tenderness around the middle. These are signs that your liver may not be functioning as well as usual.

•    Palpitations, chest pains for the first time or chest pains becoming more frequent, breathlessness, swollen ankles, hot and painful hands or feet.

•    Swelling of the limbs.

The most common side effect is constipation. Other side effects include abnormal heart heat (including increased or decreased heart rate, or irregular heart beat), low blood pressure, flushing of the face or neck, headaches, feeling or being sick, abdominal pain or discomfort, dizziness, vertigo tinnitus (ringing or buzzing in the ears), tiredness, tremor, movement disorders, muscle weakness, Stevens Johnson Syndrome symptoms of which include fever, sore throat and generally not feeling very well. Accompanied by an intense skin rash and lesions which may occur on the face, upper body, arms, legs and soles of feet. Ulcers and blisters can occur in mucous membranes such as inside the mouth, nostrils and eyelids (a severe form of conjunctivitis) but also in genital and anal regions. A tingling or prickling feeling on the skin, numbness and hair loss. Impotence may occur rarely.

Other side effects might occur if UNIVER is used for a long time. Tell your doctor if you develop swollen gums which start to spread over your teeth or if your breasts swell (males) or start to produce milk (males and females). This may be associated with an increase in a blood hormone called prolactin. These effects are rare and are resolved upon stopping taking the tablets.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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

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

5.    How to store UNIVER

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

Keep the tablets in the pack and do not store above 25°C.

Do not use after the expiry date shown on the carton and blister pack.

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.    Contents of the pack and other information What UNIVER contains

The active ingredient is verapamil hydrochloride. The capsules contain either 120 mg, 180 mg or 240 mg of the active ingredient.

In addition the capsules also contain fumaric acid, sugar spheres (containing sucrose and maize starch), talc, povidone, shellac, gelatine, titanium dioxide (E171), yellow iron oxide (E172), erythrosine (E127), indigotine (E132), black iron oxide (E172), Simethicone and propylene glycol (E1520) as inactive ingredients.

What UNIVER looks like and the contents of the pack

The 120 mg capsules are blue and yellow and marked V120. The 180 mg capsules are yellow and marked V180 and the 240 mg capsules are blue and yellow and marked V240.

The capsules are available in blister packs containing 28 or 56 capsules.

Marketing Authorisation Holder

Cephalon UK Limited,

Ridings Point,

Whistler Drive,

Castleford,

West Yorkshire,

WF10 5HX,

UK

Manufacturer

TEVA UK LIMITED,

Brampton Road, Hampden Park, Eastbourne East Sussex, BN22 9AG United Kingdom

This leaflet was last revised in September 2015.

0007/22

M Cephalon-