Lofamil Xl 300 Mg Prolonged-Release Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lofamil XL 200mg and 300mg Prolonged-release Capsules
Diltiazem 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.
What is in this leaflet:
1. What Lofamil is and what it is used for
2. What you need to know before you take Lofamil
3. How to take Lofamil
4. Possible side effects
5. How to store Lofamil
6. Contents of the pack and other information
1. WHAT LOFAMIL IS AND WHAT IT IS USED FOR
Lofamil contains a medicine called diltiazem. This belongs to a group of medicines called ‘calcium-channel blockers’.
Lofamil is used for:
• Mild to moderately increased blood pressure
• Angina (chest pain).
It works mainly by making your blood vessels wider. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood around your body. This helps to prevent the lack of oxygen in the heart muscle and thus to prevent chest pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOFAMIL Do not take Lofamil:
• if you are allergic to diltiazem or any of the other ingredients of this medicine (listed in Section 6).
• if you have a very slow heartbeat - less than 50 beats per minute
• if you have heart failure and problems with blood flow to your lungs.
• if you also use dantrolene (see “Other medicines and ‘Lofamil’” below).
• if you are already taking a medicine containing ivabradine for the treatment of certain heart
diseases.
• • if you suffer from second or third degree heart block or sick sinus syndrome (these are
problems with the electrical impulses of the heart) which may cause slow or uneven heartbeat, unless you have a working pacemaker fitted.
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 Lofamil.
Warnings and precautions
Check with your doctor or pharmacist before taking your medicine:
• if you have any heart problems such as a reduced function of the left heart chamber, bradycardia (a slow heart rate) or first degree heart block (a problem with the electrical impulses of the heart which may lead to arrhythmia).
• if you are going to have anaesthesia (e.g. during surgery). Tell your doctor that you use diltiazem.
• if you are at risk of mood changes, including depression. If any of these symptoms occur during treatment with this medicine, tell your doctor.
• if you have gut problems
• if you are an elderly patient
• if you have renal problems
• if you have liver problems.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lofamil.
Other medicines and Lofamil
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Lofamil can affect the way some other medicines work. Also some medicines can affect the way Lofamil works.
In particular, do not take this medicine and tell your doctor if you are taking:
• Dantrolene (an infusion) used for severe muscle spasms or serious fever (called ‘malignant hyperthermia’).
• Ivabradine - used for certain heart diseases
• Nifedipine
• Ergot derivatives (ergotamine, dihydroergotamine)
• Cisapride
• Sertindole
• Pimozide
The use of Lofamil concomitantly with the following medicine is not recommended:
• Nifedipine used for chest pain, high blood pressure and an uneven heartbeat
Lofamil may increase the effect of the following medicines:
• Medicines for high blood pressure such as doxazosin, tamsulosin, atenolol, propranolol or acebutolol
• Medicines used for an uneven heartbeat such as amiodarone, digoxin and dronedarone
• Medicines used for angina such as glyceryl trinitrate or isosorbide trinitrate
• Medicines used for high levels of cholesterol such as simvastatin, fluvastatin and atorvastatin
• Medicines used for sleeplessness and anxiety, such as triazolam and midazolam
• Carbamazepine - used for epilepsy
• Theophylline - used for breathing problems
• Lithium - used for some types of mental illness
• Methylprednisolone - used for inflammation and allergic reactions
• Immunosuppressants (ciclosporine, tacrolimus, sirolimus) - used to stop the rejection of organs after a transplant.
Lofamil may make the following medicine work less well:
• Rifampicin - used for tuberculosis.
The following medicines can increase the effect of Lofamil
• Medicines for stomach ulcers such as cimetidine and ranitidine.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lofamil.
Pregnancy, breast-feeding and fertility
• Do not take Lofamil if you are pregnant, might become pregnant or think you may be pregnant. This is because Lofamil can cause problems for your baby. Talk to your doctor if you think you might be pregnant.
• Small amounts of Lofamil may pass into the mother’s milk. Therefore, breast-feeding during the use of Lofamil is not recommended. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicines.
• Lofamil may impair fecundation and cause fetal abnormalities.
Driving and using machines
You may feel dizzy while taking this medicine. If this happens, do not drive or use any tools or machines.
3. HOW TO TAKE LOFAMIL
Always take Lofamil exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Also ask your doctor if you feel the effect of your medicine is too weak or too strong. Do not change the dose yourself.
Taking this medicine:
• Take this medicine by mouth.
• Do not break, crush or chew your capsules.
• Swallow the capsules whole with a drink of water.
• Take before or during a meal.
How much to take Adults:
• The usual starting dose is one Lofamil 200 mg capsule a day.
If necessary, your doctor may increase your dose to:
• One Lofamil 300 mg capsule a day
• Two Lofamil 200 mg capsules a day
• One Lofamil 300 mg capsule and one Lofamil 200 mg capsule a day.
Over 65 years or adults with liver or kidney problems
• Your doctor will check you more closely particularly when you first start taking the capsules.
• The usual starting dose is one Lofamil 200 mg capsule a day.
If necessary, your doctor may increase this to:
• One Lofamil 300 mg capsule a day.
Use in children:
Lofamil should not be given to children.
If you take more Lofamil than you should
If you take more capsules than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: feeling dizzy or weak, blurred vision, chest pain, being short of breath, fainting, an unusually fast or slow heartbeat, coma, slurred speech and confusion.
If you forget to take Lofamil
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Lofamil
Keep taking Lofamil until your doctor tells you to stop. Do not stop taking Lofamil just because you feel better. If you stop, your illness may get worse.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Lofamil and see a doctor or go to a hospital straight away if:
• • You have an allergic reaction. The signs may include: a red or lumpy rash, swallowing or
breathing problems, swelling of your lips, face, eyelids, throat or tongue
• You get blistering or peeling of the skin around the lips, eyes, mouth, nose or genitals, flu-like symptoms or fever. This could be an illness called “Stevens-Johnson syndrome”
• You get a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may feel generally unwell, have a fever, chills or aching muscles. This could be an illness called “Toxic Epidermal Necrolysis”
• You have a skin rash or skin problems with a pink or red ring and a pale centre which may be itchy, scaly, or filled with fluid. The rash is most likely to happen on the palms or soles or your feet. These could be signs of a serious allergy to the medicine called “erythema multiforme”.
It is not known how often these side effects happen
Stop taking Lofamil and see a doctor or go to hospital straight away, if you notice any of the side effects above.
Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Common (affects less than 1 in 10 people)
• Slow or uneven heartbeat
• Very fast, uneven or forceful heartbeat (palpitations).
It is not known how often these side effects happen
• Skin rash caused by narrow or blocked blood vessels (called ‘vasculitis’)
• Being short of breath, feeling tired along with swollen ankles or legs. These could be signs of heart failure
• Unusual movements of the tongue, muscle spasms in your face, rolling eyes or trembling
• • High temperature, feeling tired, loss of appetite, stomach pain, feeling sick. These can be signs of inflammation of the liver (called ‘hepatitis’)
• Getting sunburnt more easily and more severely than someone not taking Lofamil. You should use sun protection whilst taking this medicine
• Breast enlargement in men.
Tell your doctor straight away if you notice any of the side effects above.
Tell your doctor as soon as possible if you have any of the following side effects:
Very common (affects more than 1 in 10 people)
• Swelling of the lower legs.
Common (affects less than 1 in 10 people)
• Indigestion, stomach pain, constipation or diarrhoea.
Uncommon (affects less than 1 in 100 people)
• Feeling dizzy, light-headed or faint when you stand or sit up quickly (low blood pressure).
Rare (affects less than 1 in 1,000 people)
• Dry mouth
• Itchy, lumpy rash (called ‘urticaria’).
It is not known how often these side effects happen
• Swollen gums.
Tell your doctor as soon as possible if you notice any of the side effects above.
Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days:
Common (affects less than 1 in 10 people)
• Headache
• Flushing (feeling of warmth)
• Feeling sick (nausea) or being sick (vomiting)
• General feeling of being unwell
• Feeling weak or tired
• Feeling dizzy
• Skin redness.
Uncommon (affects less than 1 in 100 people)
• Difficulty sleeping.
It is not known how often these side effects happen
• Mood changes, including depression
• Bleeding or bruising under the skin.
Tell your doctor or pharmacist if any of the side effects above get serious or last longer than a few days. Blood tests
Lofamil can change the levels of liver enzymes shown up
in blood tests. This can mean that your liver is not working properly.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
5. HOW TO STORE LOFAMIL
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 carton and on the blister after ‘EXP’. The expiry date refers to the last day of that month.
Store in the original packaging.
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 Lofamil 200 mg and Lofamil 300 mg contain
• • Each Lofamil 200 mg capsule contains 200 mg of the active substance Diltiazem Hydrochloride. The other ingredients are povidone, talc, ethylcellulose, stearic acid, gelatin and titanium dioxide (E171).
• Each Lofamil 300 mg capsule contains 300 mg of the active substance Diltiazem Hydrochoride.The other ingredients are povidone, talc, ethylcellulose, stearic acid, gelatin, titanium dioxide (E171), quinoline yellow (E104) and indigotine carmine (E132).
What Lofamil 200 mg and Lofamil 300 mg look like and contents of the pack
• Lofamil 200 mg capsules are opaque capsules with a white body and cap, which contain white and whitish prolonged-release pellets.
• Lofamil 300 mg capsules are opaque capsules with a white body and green cap, which contain white and whitish prolonged-release pellets.
• The capsules are provided in transparent blister packs containing 28, 30, 56, 60, 84, 90, 98, 100, 50x1 prolonged-release capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Pharmaceutical Works Private Limited Company, Pallagi ut 13, 4042 Debrecen, Hungary OR*
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
OR*
GALIEN LPS, 98 Rue Bellocier, 89100 Sens, France OR*
Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands OR*
Merckle GmbH, Ludwig-Merckle-StraBe 3, 89143 Blaubeuren, Germany OR*
TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Only the actual site of batch release will appear on the printed version of the leaflet
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in 08/2016
PL 00289/1648 PL 00289/1649