Tildiem La 300mg Prolonged-Release Capsules
Previously Assessed against UK PIL dated June 2016
PACKAGE LEAFLET: INFORMATION FOR THE USER Tildiem® LA 300mg Prolonged Release Capsules
(diltiazem hydrochloride)
Your medicine is known as the above but will be referred to as
Tildiem LA throughout the remainder of this leaflet.
This product is available in multiple strengths and all strengths will
be referred to throughout this leaflet.
Read all of this leaflet carefully before you start taking this
medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• 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
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Methylprednisolone used for inflammation and allergic reactions
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The following medicines can increase the effect of Tildiem LA:
• Medicines for stomach ulcers such as cimetidine and ranitidine
1. What Tildiem LA is and what it is used for
In this leaflet:
1. What Tildiem LA is and what it is used for
2. Before you take Tildiem LA
3. How to take Tildiem LA
4. Possible side effects
5. How to store Tildiem LA
6. Further information
Tildiem LA contains a medicine called diltiazem hydrochloride. This belongs to a group of medicines called 'calcium-channel blockers'.
It works 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 the body. This helps to prevent the chest pain caused by angina.
Tildiem LA with food and drink
It is advisable to limit the amount of grapefruit juice you drink while taking Tildiem LA as it can increase the blood levels of the active ingredient diltiazem and may increase your chance of getting side effects. If you are concerned you should stop drinking grapefruit juice and consult your doctor.
Pregnancy and breast-feeding
• You should not take Tildiem LA if you are pregnant, might become pregnant or think you may be pregnant. This is because Tildiem LA can cause problems for your baby. Talk to your doctor if you might be pregnant.
• Do not breast-feed if you are taking Tildiem LA. This is because small amounts may pass into mothers' milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine
Tildiem LA is used for:
• High blood pressure
• Angina (chest pain)
Driving and using machines
You may feel dizzy while taking this medicine.
If this happens, do not drive or use any tools or machines.
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Do not take this medicine and tell your doctor if:
x You are allergic (hypersensitive) to diltiazem hydrochloride or any of the other ingredients of Tildiem LA (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
x You are breast-feeding or planning to breast-feed (see Section below: 'Pregnancy and breastfeeding') x You are having a medicine called dantrolene used for severe muscle spasms or severe fever (see Section below: 'Taking other medicines')
x You have a very slow heartbeat - less than 50 beats per minute x You are already taking a medicine containing ivabradine for the treatment of certain heart diseases x You have heart failure and problems with blood flow to your lungs. With these illnesses, you may feel out of breath and have swollen ankles
x You have any other serious problems with your heart. This includes having an uneven heartbeat (unless you have a pacemaker)
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 Tildiem LA.
Take special care with Tildiem LA
Check with your doctor or pharmacist before taking your medicine if:
▲ You have any other problem with your heart, apart from angina or those described in the previous section
▲ You are going to have an operation
▲ You are at risk of mood changes, including depression
▲ You are at risk of gut problems
Your doctor will check you more closely particularly when you first start taking the capsules if:
▲ You are over 65 years old
▲ You have liver or kidney problems
▲ You have diabetes
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Tildiem LA.
Taking other medicines
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 Tildiem La can affect the way some other medicines work. Also some medicines can affect the way Tildiem LA 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 severe fever (called 'malignant hyperthermia')
• Medicines containing ivabradine used for the treatment of certain heart diseases
Tildiem LA 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 and digoxin
• Medicines used for angina such as glyceryl trinitrate or isosorbide trinitrate
Always take Tildiem LA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Please find below a translation of the days of the week printed on the blister.
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
• If you feel the effect of your medicine is too weak or too strong do not change the dose yourself, but ask your doctor
How much to take Adults:
Angina and high blood pressure:
• The usual starting dose is one Tildiem LA 200mg capsule a day. If necessary, your doctor may increase this to:
• One Tildiem LA 300mg capsule a day or
• Two Tildiem LA 200mg capsules a day.
• One Tildiem LA 300mg capsule and one LA Tildiem 200mg capsule a day.
Over 65 years or adults with liver or kidney problems:
Angina and high blood pressure
• The usual starting dose is one Tildiem LA 200mg capsule a day. If necessary, your doctor may increase this dose to:
• One Tildiem LA 300mg capsule a day.
Children:
Tildiem LA should not be given to children.
If you take more Tildiem LA 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, shortness of breath, fainting, an unusually fast or slow heartbeat, slurred speech, confusion, coma and sudden death.
If, in an emergency situation, the patient is treated quickly sudden death is not only the potential outcome.
If you forget to take Tildiem LA
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 Tildiem LA
Keep taking Tildiem LA until your doctor tells you to stop. Do not stop taking them just because you feel better. If you stop, your illness may get worse.
Tests
Your doctor may do regular tests while you are taking this medicine. These might include a check on your heart and blood tests to check on your liver and kidneys.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
6. Further information
18th November 2016
Like all medicines, Tildiem LA can cause side effects, although not everyone gets them.
Stop taking and see a doctor or go to a hospital straight away if:
Frequency unknown
• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You have a red or lumpy skin rash, swollen eyelids, face, lips, throat, or tongue, difficulty breathing or swallowing.
• You get blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and 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 and have a fever, chills and aching muscles. This could be an illness called 'Toxic Epidermal Necrolysis'
• You have a skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly, or filled with fluid. The rash may appear especially on the palms or soles or your feet. These could be signs of a serious allergy to the medicine called 'erythema multiforme'
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)
Frequency unknown
• Skin rash caused by narrow or blocked blood vessels (called 'vasculitis')
• Being short of breath, feeling tired along with swollen ankles and legs. This could be signs of heart failure
• Unusual movements of the tongue, muscle spasms in your face, rolling eyes and trembling
• High temperature, feeling tired, loss of appetite, stomach pain, feeling sick. These can be signs of inflammation of the liver (called 'hepatitis')
• Passing large amounts of urine, excessive thirst and having a dry mouth or skin. These may be signs of high blood sugar (hyperglycemia).
• Get sunburnt easier, and which may be more severe than in someone not taking Tildiem. You should use sun protection whilst taking this medicine.
• Breast enlargement in men
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use Tildiem after the expiry date which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month.
Do not store above 25°C.
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.
If your capsules become discoloured or show any signs of deterioration, you should ask your pharmacist who will tell you what to do.
What Tildiem contains
• Each capsule contains 300mg of the active ingredient diltiazem hydrochloride
• The other ingredients are microcrystalline cellulose, carmellose sodium, acrylic and methacrylic esters copolymer, ethylcellulose, diacetylated monoglycerides, magnesium stearate, gelatin, titanium dioxide (E171) and yellow iron oxide (E172)
What Tildiem look like and contents of the pack
Your capsules are opaque capsules with a white body and yellow
cap, containing white to off-white pellets.
The capsules are provided in calendar blister packs 28 capsules.
Manufacturer
Manufactured by Sanofi Wihthrop Industrie, Tours, France.
Procured from within the EU and repackaged by the Product
Licence Holder: G Pharma Ltd., Unit 3 & 4 Dakota Avenue, Salford
M50 2PU.
PL 16369/1621
Leaflet Revision:
Tildiem is a registered trademark of Sanofi
POM
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, and 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 1000 people)
• Dry mouth
• Itchy, lumpy rash (called 'urticaria')
Frequency unknown
• Swollen gums
Tell your doctor or pharmacist if any of the following side effects get serious or lasts 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
• Weakness or tiredness
• Feeling dizzy
• Skin redness
Uncommon (affects less than 1 in 100 people)
• Difficulty sleeping
Frequency unknown
• Mood changes, including depression
• Bleeding or bruising under the skin
Blood tests
Tildiem can change the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly.
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
By reporting side effects you can help provide more information on the safety of this medicine.