PATIENT INFORMATION LEAFLET

Vera-Til SR Tablets 120mg & 240mg

(Verapamil Hydrochloride)

□ What Vera-Til SR is and what it is used for

The active ingredient in this medicine is called verapamil hydrochloride. It belongs to a group of medicines called calcium channel blockers which are used to treat high blood pressure, or to help control angina (chest pain). It works by reducing the heart rate and increasing coronary blood flow. Vera-Til SR Tablets may be used after a heart attack in order to prevent further heart attacks.

Before you take Vera-Til SR

Do not take Vera-Til SR Tablets if:

■    you are allergic to verapamil or any of the other ingredients. (see section 6 "Further Information " for a list of other ingredients)

■    you have had a heart attack, which has been followed by a slow heart rate, low blood pressure or breathlessness

■    you have a weak heart which may cause breathlessness and tiredness

■    you have an abnormal or slow heartbeat (unless controlled by a pacemaker) or had heart block

■    you have had congestive heart failure

■    you have low blood pressure

■    you have blocked veins in your heart

■    you have Wolff-Parkinson-White syndrome

Warnings and precautions

Take special care with Vera-Til SR Tablets - Tell your doctor if any of the following apply to you:

■    If you have liver disease

■    If you have kidney disease

■    If you have suffered heart failure or have heart problems

■    If you are taking statins for lowering cholesterol, such as simvastatin, atorvastatin or lovastatin (see section 2 'Taking other medicines')

■    If you have a neuro-muscular disorder such as myasthenia gravis (chronic fatigue and muscular weakness), Lambert-Eaton syndrome or advanced Duchenne muscular dystrophy

Blood pressure should regularly be checked when being treated with Vera-Til SR Tablets.

Children and adolescents

There are no data on the use of Vera-Til SR Tablets in children and adolescents.

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken any other medicines, even those not prescribed but bought without a prescription, or the following:

Other medicines which may interact with Vera-Til SR Tablets:

■    Aspirin, a non-steroidal anti-inflammatory painkiller (NSAID), used to relieve pain and reduce fever

■    Medicines for high blood pressure and heart conditions such as:

-    prazosin and terazosin (alpha blockers)

-    propanolol and metoprolol (beta-blockers)

Vera-Til must not be taken with beta-blockers given by injection

-    water tablets (diuretics)

-    vasodilators, such as hydralazine

■    Medicines for irregular heart beat or heart failure (cardiac glycosides), such as digoxin and digitoxin

■    Other medicines for irregular or rapid heartbeat, (anti-arrhythmics), such as flecainide, quinidine

■    Medicines for epilepsy (anti-convulsants), such as carbamazepine and phenytoin

■    Medicines for depression, such as imipramine (anti

depressants) and St. John's Wort (herbal product)

■    Glibenclamide, for certain types of diabetes

■    Medicinces used to prevent rejection after organ transplants (immunosuppressants), such as ciclosporin, everolimus, tacrolimus or sirolimus,

■    Theophylline, for bronchial asthma

■    Rifampicin, an antibiotic for various infections, in particular tuberculosis

■    Lithium, for depression or mania

■    Cimetidine, for the treatment and prevention of ulcers and to reduce stomach acidity

■    Ivabradine, for chest pain (angina)

■    Erythromycin, telithromycin and clarithromycin, for bacterial infections

■    Doxorubicin, for cancer

■    Medicines used for lowering cholesterol (known as 'statins'), such as simvastatin, atorvastatin and lovastatin

■    Barbiturates, for anxiety, difficulty sleeping and epilepsy, such as phenobarbital and primidone

■    Buspirone, for anxiety

■    Midazolam, used as a sedative or anaesthetic

■    Colchicine and sulfinpyrazone for gout

■    Ritonavir, for HIV

■    Almotriptan, used to treat migraine

■    Anaesthetics which are inhaled

■    Medicines used to relax and paralyse muscles before an operation, such as atracurium

Taking Vera-Til SR Tablets with food and drink

Do not drink grapefruit juice whilst taking this medicine.

The consumption of alcohol should be avoided when taking Vera-Til SR Tablets.

Pregnancy and breast-feeding Pregnancy

Do not use this product if you are pregnant, think you are pregnant or planning a family, unless your doctor has told you that it is safe to do so.

Vera-Til SR Tablets should not be given during the first trimester of pregnancy unless your doctor has told you that it is safe to do so.

Breast-feeding

Do not use this product if you are breast-feeding unless your doctor has told you that it is safe to do so.

Driving or using machinery

Vera-Til may influence your ability to drive, use machinery or work under hazardous conditions. If this happens, especially at the beginning of treatment or increasing the dose, do not drive or work machinery and consult your doctor or pharmacist.

Important information about some of the ingredients of Vera-Til SR Tablets

Veratil SR Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Vera-Til SR Tablets

Always take Vera-Til SR Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

■    Vera-Til SR Tablets should be taken orally

■    Vera-Til SR Tablets should be swallowed whole with some liquid

The usual dose is:

Adults:

High blood pressure: The usual dose is one 240mg Vera-Til SR Tablet daily. If you are new to verapamil

continued....

therapy, your doctor may prescribe half the usual dose, one Vera-Til SR Tablet 120mg daily. Most patients respond to 240mg daily given as a single dose.

A maximum dosage of two Vera-Til SR 240mg Tablets daily (one taken in the morning and one in the evening at an interval of about 12 hours) may be administered if control is not achieved within at least one week of therapy.

Your doctor may prescribe other high blood pressure medicine if your blood pressure needs further reduction.

Angina: The usual dose is one 240mg Vera-Til SR Tablet twice a day. A few patients respond to a lower dose and where suitable, can take one 240mg Vera-Til SR Tablet once a day.

Prevention of further heart attack: Treatment should commence at least one week after a heart attack.

Vera-Til SR Tablets can be taken in divided doses either as 120mg three times daily, or as 240mg to be taken in the morning and 120mg to be taken in the evening on a daily basis.

Elderly:

The adult dose is recommended, except in patients with liver or kidney problems, where a reduced dosage may be necessary.

Children:

Vera-Til SR Tablets are not recommended for children.

After long-term treatment, your doctor will gradually discontinue verapamil therapy.

Your doctor may prescribe a different dose to the above. If this is the situation, you should discuss it with your doctor or pharmacist.

It is important that you keep on taking Vera-Til SR Tablets until the prescribed dose has finished. Do not stop taking the tablets even though you may feel better.

If you have taken more Vera-Til SR tablets than you should

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice.

If you forget to take Vera-Til SR Tablets

Take them as soon as you remember. Do not take a double dose to make up for the forgotten individual dose.

Possible side effects

Like most medicines, Vera-Til SR Tablets can cause side effects, although not everybody gets them.

Serious side effects

If you experience any of the following you should see your doctor as soon as possible as you may have stop taking the tablets

■    Heart problems such as:

-    slower, faster or irregular heart beat

-    tiredness, feeling your heart beat (palpitations), breathlessness, fainting

-    swelling of ankles, legs or stomach dizziness or fainting, especially when going from sitting or lying position to standing up

■    Blistering of the skin, mouth, eyes and genitals (Steven-Johnson syndrome)

Rare side effects

■    Flushing

■    Unable to have an erection (erectile dysfunction)

■    Feeling of dizziness or "spinning" (vertigo)

■    Ringing in the ears (tinnitus)

■    Feeling sick (nausea)

■    Being sick (vomiting)

■    Constipation

■    Stomach pain

■    Swelling up of the ankle (ankle oedema)

■    Hereditary condition which causes painless swelling of face, tongue, feet, genitals and front of body (Quincke's oedema)

■    Red patches on the skin

■    Skin rash due to bleeding into the skin

■    Burning pain in the hands and/or feet which feel hot and are red in colour (erythromelalgia)

■    Hair loss (alopecia)

■    Muscle weakenss

■    Muscular pain (myalgia)

■    Joint pain (arthraliga)

■    Mental or physical tiredness (fatigue)

■    Breasts produce milk (women & men)

■    Increase in the level of the hormone prolactin (detected through blood test)

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

How to store

Keep out of reach and sight of children.

Do not store above 25°C.

Do not use Vera-Til SR Tablets after the expiry date which is stated on the carton/bottle after "EXP". The expiry date refers to the last day of the 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.

Further information

What Vera-Til SR Tablets contain:

The active substance in Vera-Til SR sustained release tablets is verapamil hydrochloride.

Other ingredients are sodium alginate 80 cP x H2O, Microcrystalline cellulose 90mm, povidone, magnesium stearate and colloidal anhydrous silica.

The film coating for Vera-Til SR 120mg Tablets is opadry, white which consists of lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000 and yellow ferric oxide (E172).

The film coating for Vera-Til SR 240mg Tablets is opadry, white and green varnish. Opadry, white consists of lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000 and quinoline yellow (E104).

Green varnish consists of quinoline yellow (E104) and indigotine (E132).

What Vera-Til SR Tablets look like and contents of the pack

Vera-Til SR 120mg Tablets are round, beige to ochre, biconvex, sustained release film coated tablets with a score on one side.

Vera-Til SR 240mg Tablets are oblong, light green, sustained release film coated tablets with a score on both sides.

Very rare side effects

■    Allergic reactions like -

-    Redness and swelling of the skin (erythema)

-    Itching (pruritus)

-    Itchy rash (urticaria)

■    Liver problems such as an increase in liver enzymes (detected through blood test). Usually reversible after stopping the tablets

■    Enlargement of the male breast-usually in elderly male patients (gynaecomastia). Usually due to long term treatment and reversible after stopping the tablets

■    Enlargement of the gums (gingival hyperplasia). Usually due to long term treatment and reversible after stopping the tablets

Other side effects

■    Headaches

■    Dizziness

■    Pins and needles sensation (paraesthesia)

■    Shaking

■    Movement disorders

Vera-Til SR is available in: Vera-Til SR Tablets are available in packs of 28, 30, 56 and 100 tablets.

Marketing Authorisation Holder:

Tillomed Laboratories Ltd 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire,

PE198ET United Kingdom.

Manufacturer

Salutas Pharma GmbH Otto-von-Guericke Allee 1 39179 Barleben Germany

Product Licence Numbers:

Vera-Til SR Tablets 120 mg: PL 11311/0077 Vera-Til SR Tablets 240 mg: PL 11311/0078

Date of revision: August 2013

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