Verapamil 80mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
VERAPAMIL 40 mg, 80 mg & 120 mg TABLETS
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 signs of illness 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.
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This leaflet contains
1. What Verapamil tablets are and what they are used for
2. What you need to know before you take Verapamil tablets
3. How to take Verapamil tablets
4. Possible side effects
5. How to store Verapamil tablets
6. Contents of the pack and other information
1. What Verapamil tablets are and what they are used 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. What you need to know before you take Verapamil tablets
Do not take Verapamil tablets 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)
• are being treated with ivabradine (for heart conditions)
• 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 tablets 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.
Warnings and precautions
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
• have a condition where the nerve to muscle transmission is affected e.g. myasthemia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy.
• 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.
Tests and operations while you are taking Verapamil tablets
• 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 tablets.
Other medicines and Verapamil tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines bought without a prescription. This is because Verapamil tablets can affect the way some medicines work. Also some medicines can affect the way Verapamil tablets works.
In particular, tell your doctor or pharmacist if you are taking any of the following:
• Medicines to treat heart failure, such as Digoxin, Digitoxin or Eplerenone
• Medicines used to lower blood pressure and treat abnormal heart rhythms, such as beta blockers
(e.g. Atenolol, Metoprolol or Propranolol), Alpha blockers (e.g. Prazosin and Terazosin), Amiodarone, Disopyramide, Flecainide or Quinidine
• Dabigatran, used to thin the blood
• Medicines containing ivabradine for the treatment of certain heart diseases
• Simvastatin, atorvastatin or lovastatin used to lower cholesterol levels
• Diuretics (also called ‘water pills’)
• 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 and the herbal product St John’s Wort
• Buspirone to treat anxiety
• Theophylline to treat asthma
• Rifampicin to treat TB (tuberculosis)
• Atazanavir or Ritonavir to treat HIV (Human Immunodeficiency Virus)
• Clarithromycin, Erythromycin or Telithromycin to treat bacterial infections
• Cimetidine to treat stomach ulcers
• Ciclosporin, Everolimus, Sirolimus or Tacrolimus used to stop the rejection of organs after transplants
• 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
• 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.
• Doxorubicin, an anti-cancer medicine
• Colchicine or suplfinpyrazone used to treat gout
If you go into hospital or have treatment for other conditions, tell the doctor you are taking Verapamil tablets
Verapamil tablets with food and drink
• do not drink grapefruit juice whilst taking Verapamil tablets. 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 tablets. 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, think you might be pregnant, planning to have a baby 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 Verapamil tablets, you may find that your ability to drive a car or use machinery is impaired. You should take care when driving or using machines until you know how you react to this medicine.
Verapamil tablets contains
• lactose (a type of sugar). If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine.
• sunset yellow (E110), which may cause allergic reactions.
3. How to take Verapamil tablets
Always take Verapamil tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Swallow this medicine with a glass of water
Adults
The recommended 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 recommended 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 tablets 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 tablets
Take your tablets 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 tablets
Do not stop taking this medicine without talking to your doctor first. If you stop taking this medicine it may make your condition worse.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Verapamil tablets 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:
• 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.
• 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
• swelling of the limbs
If you get any of the following side effects, see your doctor as soon as possible:
• swelling of your blood vessels which may show as pain in the fingers and toes
• numbness or tingling
• muscle or joint pain
The most common side effect is constipation. Other side effects include;
• muscle weakness
• tremor or movement disorders
• breast development in older men or breasts start to produce milk (males and females). These effects are rare and are resolved upon stopping taking the tablets
• difficulty in getting an erection
• flushing of your face
• skin rash or itching
• hair loss
• headaches, feeling dizzy or tired
• tinnitus (ringing or buzzing in the ears)
• vertigo
• abdominal pain or discomfort
• 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.
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.
5. How to store Verapamil tablets
Keep this medicine out of the sight and reach 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 this medicine after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other 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.
Al three strengths of Verapamil Tablets come in blister packs of 28 and 84 tablets and in containers of 100 and 500 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 03/2016
M0068-0069-0070/0/PIL/M1