Patient leaflet - Viazem XL 360 mg
1. WHAT VIAZEM® XL IS AND WHAT IT IS USED FOR
The active ingredient in this medicine is called diltiazem. It belongs to a group of medicines called calcium antagonists which are used to treat high blood pressure, or to help control angina.
2. BEFORE YOU TAKE VIAZEM® XL
Do not take Viazem® XL if:
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you are allergic to diltiazem or any of the other ingredients in Viazem® XL (see list under ‘What Viazem® XL contains). Azorubine can cause allergic reactions including asthma. Allergy is more common in those people allergic to aspirin.
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you have serious heart problems, particularly if a doctor has told you that you have any of the following conditions; - Severe bradycardia (a very slow pulse)
- Heart block or pre-excitation syndrome or sick sinus syndrome (conditions in which there are problems with the control of your heart rate)
- Left ventricular failure
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you are already taking a medicine containing invabradine for the treatment of certain heart diseases
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you are already taking a medicine containing lomitapide used for the treatment of high cholesterol levels (see section: ‘Other medicines and Viazem® XL’)
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you have unstable angina
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the patient is a child
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you are pregnant or are breast-feeding.
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f you are not sure, talk to your doctor or pharmacist before taking this medicine. Take special care with Viazem® XL:
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if you have a history of heart failure, new shortness of breath, slow heartbeat or low blood pressure. As cases of kidney injury in patients with such conditions have been reported, your doctor may need to monitor your kidney function.
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If you have suffered from any other heart problems.
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if you have suffered a stroke.
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if you have had liver or kidney problems.
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if you suffer from Crohn’s disease or ulcerative colitis.
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f you are not sure, talk to your doctor or pharmacist.
Other medicines and Viazem® XL
Please tell your doctor or pharmacist if you are taking or have recently taken any medicines, including medicines obtained without a prescription, in particular, do not take this medicine and tell your doctor if you are taking:
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any other drug that has been prescribed to treat your blood pressure or any heart condition that you have, such as digitoxin.
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medicines containing lomitapide used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of the lomitapide that may lead to an increase in the likelihood and severity of liver related side effects. Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist. Diltiazem may inhibit the breakdown of certain medicines such as statins. This may lead to an increased and/or prolonged e
ffect of these medicines including an increased number and severity of side-effects, such as muscle weakness and i
nflammation or liver infection.
Pregnancy and breast-feeding
You should not take this medicine if you are pregnant or are breast-feeding. Women of child-bearing potential should exclude t
he possibility of pregnancy before commencing treatment. If it is at all possible that you could become pregnant while taking t
his medicine you should use suitable contraception. You may wish to discuss this with your doctor. Because diltiazem passes into breast milk, breast-feeding must be stopped while taking this medication.
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mportant information about some of the ingredients of Viazem® XL
T
he 120mg, 240mg and 300mg capsules contain azorubine (E122). Azorubine can cause allergic reactions including asthma. Allergy is more common in those people allergic to aspirin.
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f you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE VIAZEM® XL
Always take Viazem® XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not s
ure. Viazem® XL capsules have been specially designed so that you only have to take your capsules once a day. However, y
ou must carry out the following steps to allow your medicine to work properly:
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You must take this medicine as prescribed by your doctor. Usually this will be one capsule to be taken at the same time each day, preferably just before or during a meal.
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You should swallow the whole capsule, preferably with a glass of water. Do not bite, chew or suck the capsule otherwise the medicine will not work properly.
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Do not stop taking this medicine before telling your doctor.
If you take more Viazem® XL than you should
If you take more tablets 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, decrease of kidney function, coma, and sudden death.
If you forget to take Viazem® XL
If you forget to take a dose, take it as soon as you remember then take the next one the following day, making sure that you leave at least a twelve hour period between the two. Do not take a double dose to make up for a forgotten capsule. Do not give Viazem® XL to children.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, Viazem® XL can cause side-effects, although not everybody gets them. Allergic skin rashes may range in severity from mild to itchy skin eruptions to a rarer serious condition called Stevens-Johnson syndrome, which may cause fever, chills, ulceration of the mouth, lips or skin. If you experience symptoms suggestive of Stevens-Johnson syndrome, please consult your doctor or go to your nearest hospital casualty department immediately.
Although most people do not have any problems using this medicine, a number of side-effects may occasionally occur, including:
- leg or ankle swelling
- dizziness
- vomiting
- headache
- stomach upset
- constipation
- flushing
- diarrhoea
- skin rash
- a condition in which the body’s defence system attacks normal tissue causing symptoms such as swollen joints, tiredness and rashes (called ‘lupus-like syndrome’)
- tiredness
- nausea (a feeling of sickness)
Important information about your medicine
You may find what appears to be a capsule shell in the toilet. Do not be concerned, as this outer shell does not have to be digested by the body. It does not mean that your medicine is not working. If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.
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.
5. HOW TO STORE VIAZEM® XL
Keep this medicine out of the sight and reach of children.
Do not take Viazem® XL after the expiry date on the carton. The expiry date is printed on one of the cardboard carton flaps and on the foil blister pack. The expiry date refers to the last day of the month.
Do not store above 25ºC.
Store in original package and in a dry place away from any heat source, e.g. direct sunlight, heaters, steam, etc. Return all unused capsules to your pharmacist. Only keep them if your doctor tells you to. 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. FURTHER INFORMATION
What Viazem® XL contains
The active substance in Viazem® XL prolonged release capsules is diltiazem hydrochloride. The other ingredients are sucrose stearate, microcrystalline cellulose (E460), polyvidone, magnesium stearate, talc, methyl hydroxypropylcellulose, polysorbate 80, polyacrylate dispersion and simethicone emulsion. The gelatin capsules contain the following colouring agents: Lavender opaque contains the colourants azorubine (E122), indigotine (E132) and titanium dioxide (E171), white opaque consists of titanium dioxide (E171) and blue green opaque contains quinoline yellow (E104), indigotine (E132) and titanium dioxide (E171).The white printing ink used in your medicine contains shellac, ethyl alcohol, isopropyl alcohol, n-butyl, propylene glycol, sodium hydroxide, polyvinylpyrrolidone and titanium dioxide. The black printing ink contains shellac, ethyl alcohol, isopropyl alcohol, n-butyl, propylene glycol, ammonium hydroxide, potassium hydroxide and black iron oxide. What Viazem® XL looks like and contents of the pack
Viazem® XL prolonged release capsules are available in five different strengths to help your doctor to prescribe the right amount of diltiazem to lower your blood pressure or control your angina; 120mg, 180mg, 240mg, 300mg and 360mg.
Capsule body Capsule cap
120mg capsule Lavender opaque Lavender opaque
180mg capsule White opaque Blue green opaque
240mg capsule Blue green opaque Lavender opaque
300mg capsule White opaque Lavender opaque
360mg capsule Blue green opaque Blue green opaque
Each pack contains 28 capsules.
POM
Marketing Authorisation Holder:
Thornton & Ross Ltd., Linthwaite, Huddersfield, HD7 5QH, UK.
Manufacturer:
SMB Galephar SA, Rue de la Pirire 39, 6900 Marche-en-Famenne, Belgium.
Thornton & Ross Ltd., Linthwaite, Huddersfield, HD7 5QH, UK.
This leaflet was last revised in May 2023
Please read the back of this leaflet.
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Trademark
*Trademark 92798142305
92798142305
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