Patient leaflet - BI-carzem SR 90 mg prolonged-release hard capsules
1. What Bi-Carzem SR is and what it is used for
Bi-Carzem SR contains a medicine called diltiazem hydrochloride. It 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. Bi-Carzem SR is used to treat:
- Chest pain (angina)
- High blood pressure
2. What you need to know before you take Bi-Carzem SR
Do not take Bi-Carzem SR if:
- You are allergic to diltiazem hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- You are breast-feeding or planning to breast-feed (see "Pregnancy and breast-feeding" section)
You have heart problems, such as:
o very slow heartbeat - less than 50 beats per minute
(severe bradycardia)
o dizziness, fainting, chest pain, light-headedness or
shortness of breath, unless you have a pacemaker (second or third degree heart block)
o dizziness, fainting, confusion, palpitations, shortness
of breath or tiredness, unless you have a pacemaker (sick sinus syndrome)
o shortness of breath, excessive sweating, anxiety and
pale skin (left ventricular failure with lung congestion)
You are already taking a medicine containing ivabradine for the treatment of certain heart diseases
(see "Other medicines and Bi-Carzem SR" section)
- You are already taking a medicine containing lomitapide used for the treatment of high cholesterol levels (see "Other medicines and Bi-Carzem SR" section)
- You are already taking a medicine containing asunaprevir used for the treatment of hepatitis C virus infection (see "Other medicines and Bi-Carzem SR" section).
You are being treated with dantrolene injection (for severe muscle spasm or severe fever)
(see "Other medicines and Bi-Carzem SR" section)
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine 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
- you have any other problems with your heart rhythm or reduced heart function
- you are going to have an operation and will have anaesthesia
- you are at risk of mood changes, including depression
- you are at risk of gut problems
- you are taking blood thinners such as direct-acting oral anti-coagulants (e.g. dabigatran, rivaroxaban, apixaban) (see “Other medicines and Bi-Carzem SR” section)
Your doctor will check you more closely, particularly when you first start taking the capsules, if:
- you are elderly (over 65 years old)
- you have liver or kidney problems
- you have diabetes
- you have or ever had asthma
- you take any beta blocker medicines (see “Other medicines and Bi-Carzem SR” section)
Other medicines and Bi-Carzem SR:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.
Bi-Carzem SR should not be taken with the following:
Dantrolene infusion, used to relieve severe muscle spasm or severe fever (called malignant hyperthermia) for conditions such as cerebral palsy, multiple sclerosis or spinal cord injury
- Medicines containing ivabradine, used for the management of stable heart-related chest pain and heart failure
- 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
- Medicines containing asunaprevir used for the treatment of hepatitis C virus infection. Diltiazem may increase the concentration of the asunaprevir that may lead to an increase in the likelihood and severity of liver-related side effects.
Other medicines which may interact with or be affected by Bi-Carzem SR:
- Medicines used to treat high blood pressure such as doxazosin, tamsulosin, atenolol, propranolol or acebutol
- Medicines used for the treatment of irregular heartbeat (e.g. amiodarone) or heart failure (e.g. digoxin)
- Medicines for chest pain (angina) such as glyceryl trinitrate or isosorbide dinitrate (nitrates)
- Medicines with the potential/known for prolonging the QT interval
- Carbamazepine, phenytoin, used to treat epilepsy
- Iodinated contrast media (used for tests involving X-rays)
- Theophylline, used to treat bronchial asthma
- Ciclosporin, used to prevent rejection of transplant organs
- Medicines used to treat stomach ulcers (e.g. cimetidine or ranitidine)
- Lithium, used to treat depression or mania
- Rifampicin, an antibiotic used to treat various infections, in particular tuberculosis
- Antiplatelet medicines used to reduce the chance of blood clots forming, such as aspirin or clopidogrel
- Blood thinners such as direct-acting oral anti-coagulants (e.g. dabigatran, rivaroxaban, apixaban)
- Midazolam, triazolam, used to induce sleepiness or drowsiness before an operation, during minor surgery or as a premedication
- Statins, used to treat high cholesterol e.g. atorvastatin, fluvastatin or simvastatin
- Methylprednisolone (corticosteroid), used to treat inflammation
- Cilostazol, used to treat intermittent cramp-like leg pain when walking caused by insufficient blood supply
- Colchicine, used to treat gout
Tests
Your doctor may do regular heart and blood tests while you are taking this medicine to check on your liver and kidneys.
Bi-Carzem SR with food and drink
It is advisable to limit the amount of grapefruit juice you drink while taking Bi-Carzem SR 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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
You should not take this medicine if you are pregnant, might become pregnant or think you may be pregnant. Bi-Carzem SR can cause problems for your baby. Talk to your doctor if you think you might be pregnant.
Breast-feeding
- Do not breast-feed if you are taking Bi-Carzem SR as small amounts of diltiazem may pass into breast milk
- If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking this medicine.
Driving and using machines
You may feel feeling dizzy while taking this medicine. If affected, you should not drive or operate machinery.
Bi-Carzem SR contains sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Bi-Carzem SR
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your medicine comes in a prolonged-release hard gelatin capsule which means the medicine is released over a longer period of time.
- This medicine is for oral use
- You should swallow the capsule whole, with a little water
- Do not chew or crush the capsules
- You may notice remains of the medication (the capsule shell) in your stools. This has no clinical relevance as your body has already absorbed the medicine.
The recommended dose is:
Adults
Angina and high blood pressure:
The usual starting dose is one 60 mg capsule three times a day (180 mg per day) or one 90 mg capsule twice a day PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BI-CARZEM SR 60 mg, 90 mg and 120 mg
Prolonged-release Capsules
(diltiazem hydrochloride)
Bi-Carzem [Diltiazem HCl] Package leaflet
TBA/Till-Ver.12.3
TW197973 (SmPC)
UK
All
NA
TBA
9 points (Reg text)
TW163719 Till-Ver.12.2 25/07/2025
25/07/2025
13/04/2026
Black C
(180 mg per day) or 120 mg capsule twice a day (240 mg per day).
If necessary, your doctor may increase this to 360 mg per day or 480 mg per day, given in divided doses.
Elderly or patients with liver or kidney problems Angina:
The recommended starting dose is one 60 mg capsule twice a day (120 mg per day).
If necessary, your doctor may increase this to one 90 mg capsule twice a day (180 mg per day) or one 120 mg capsule twice a day (240 mg per day).
High blood pressure:
The usual starting dose is one 120 mg capsule a day.
If necessary, your doctor may increase this to one 90 mg capsule twice a day (180 mg per day) or one 120 mg capsule twice a day (240 mg per day).
Use in children
This medicine is not recommended for use in children.
If you take more Bi-Carzem SR than you should
If you accidentally take too many capsules, contact your doctor or go to the nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining capsules with you.
Symptoms of overdose include: 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. Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may develop up to 24-48 hours after intake.
If, in an emergency situation, the patient is not treated quickly sudden death is not only the potential outcome.
If you forget to take Bi-Carzem SR
Take it as soon as you remember unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.
If you stop taking Bi-Carzem SR
It is important that you keep taking Bi-Carzem SR for as long as your doctor has told you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them.
Seek medical advice immediately if you develop the following symptoms:
- Allergic reactions: swelling of the face, throat or tongue, fever, difficulty in breathing, dizziness
- Abnormal heart rhythm where the heart beats too slowly (AV block, sinoatrial block, congestive heart failure) or stops beating (sinus arrest, cardiac arrest)
- Swelling of the deeper layers of the skin caused by a build-up of fluid (angioneurotic oedema)
- Severe blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Difficulty breathing or wheezing (bronchospasm, aggravation of asthma)
Other possible side effects
Very common side effect (may affect more than 1 in 10 people)
- Swelling of the calves, ankles or feet
Common side effects (may affect up to 1 in 10 people)
- Headache
- Dizziness
- Flushing of the skin
- Feeling your heartbeat (palpitations)
- Generally feeling unwell
- Indigestion, stomach pain, feeling sick, constipation
- Skin rashes (erythema)
Uncommon side effects (may affect up to 1 in 100 people)
- Difficulty sleeping
- Nervousness
- Slower heartbeat
- Low blood pressure causing dizziness or lightheadedness after a change in position i.e. when standing up from a lying or sitting position
- Being sick
- Diarrhoea
- Increase in liver enzymes (detected through a blood test)
Rare side effects (may affect up to 1 in 1,000 people)
- Dry mouth
- Skin rash rashes with the formation of wheals (urticaria)
Not known (frequency cannot be estimated from the available data)
- Sweating
- Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
- Mood changes including depression
- Medicine-induced movement disorders (Extrapyramidal Syndrome)
Swollen gums
- Increased blood sugar levels (hyperglycaemia)
- Excessive development of the male breast
- Peeling of the skin over large areas of the body (exfoliative dermatitis)
- Small raised bumps on the skin that fill with fluid or pus caused by a hypersensitivity (allergy) to medicine (Acute Generalised Exanthematous Pustulosis (AGEP))
- Rash, scaling of the skin (with or without fever)
- Inflammation of blood vessels (vasculitis)
- Increased sensitivity of the skin to sunlight (photosensitivity)
- Inflammation of the liver (hepatitis)
- 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')
- Rash that may occur on the skin or sores in the mouth (lichenoid drug eruption).
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Bi-Carzem SR
- 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/blister after 'EXP'. The expiry date refers to the last day of that month.
- Store below 25°C in a dry place away from heat.
- Store in the original package in order to protect from moisture.
- 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 Bi-Carzem SR contains
- Each Bi-Carzem 60 mg prolonged release capsule contains 60 mg of active substance diltiazem hydrochloride in sustained release sugar beads
- Each Bi-Carzem 90 mg prolonged release capsule contains 90 mg of active substance diltiazem hydrochloride in sustained release sugar beads
- Each Bi-Carzem120 mg prolonged release capsule contains 120 mg of active substance diltiazem hydrochloride in sustained release sugar beads
The other ingredients are: sucrose, corn starch, povidone, methacrylic acid copolymer, ethylcellulose, talc, diethyl phthalate, gelatin.
The capsules also contain titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172). (Bi-Carzem 120 mg does not contain iron oxide yellow).
What Bi-Carzem SR looks like and contents of the pack
- Bi-Carzem SR 60 mg: opaque pink and white capsule
- Bi-Carzem SR 90 mg: opaque pink and yellow capsule
- Bi-Carzem SR 120 mg: opaque pink and orange capsule The capsules are available in blister packs or containers containing 56 or 100 capsules.
Not all pack sizes or types may be marketed.
Product Licence Numbers:
- Bi-Carzem SR 60 mg Capsules: PL 11311/0468
- Bi-Carzem SR 90 mg Capsules: PL 11311/0469
- Bi-Carzem SR 120 mg Capsules: PL 11311/0470
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Limited
220 Butterfield, Great Marlings
Luton, LU2 8DL, United Kingdom
This leaflet was last revised in April 2026
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