Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Tildiem LA 300mg Prolonged-Release Capsules
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Diltiazem hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for 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 is used for:
- High blood pressure
- Angina (chest pain)
What you need to know before you take it
e Tildiem LA Do not take Tildiem LA if:
× You are allergic (hypersensitive) to diltiazem hydrochloride or any of the other ingredients of Tildiem LA (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. × You are breast-feeding or planning to breast-feed (see below: 'Pregnancy and breast-feeding'). × You are having a medicine called dantrolene used for severe muscle spasms or severe fever (see below: 'Other medicines and Tildiem LA'). × You have a very slow heartbeat – less than 50 beats per minute × You are already taking a medicine containing ivabradine for the treatment of certain heart diseases. × 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. × You have any other serious problems with your heart. This includes having an uneven heartbeat (unless you have a pacemaker). × You are already taking a medicine containing lomitapide used for the treatment of high cholesterol levels (see section: 'Other medicines and Tildiem LA'). 1
× You are already taking a medicine containing asunaprevir used for the treatment of hepatitis C virus infection (see section: 'Other medicines and Tildiem LA'). 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. Warnings and precautions
Talk to your doctor or pharmacist before taking Tildiem LA 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 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. ▲ You are taking blood thinners such as direct acting oral anti-coagulants (example: dabigatran, rivaroxaban, apixaban) along with Tildiem LA. Your doctor will check you more closely particularly when you first start taking Tildiem LA if: ▲ You are 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. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Tildiem LA.
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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. Tildiem LA may lead to increase in level of Colchicine (drug used to treat gout) when administered concomitantly. Tildiem LA may lead to increased risk of bleeding if taken along with blood thinners such as direct acting oral anti-coagulants (example: dabigatran, rivaroxaban, apixaban). Tildiem LA may lead to QT prolongation (ECG changes such as changes in heart rate, rhythm along with symptoms of dizziness), when administered along with drugs with the potential/known for prolonging the QT interval. 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.
- 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
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.
- Medicines used for high levels of cholesterol such as simvastatin, fluvastatin and atorvastatin.
- Ciclosporin used to stop the rejection of organs after a transplant.
- Phenytoin and carbamazepine used for epilepsy.
- Antiplatelet medicines used to reduce the chance of blood clots forming, such as aspirin or clopidogrel.
- Iodinated contrast media (used for tests involving X-rays).
- Theophylline used for breathing problems.
- Lithium used for some types of mental illness.
- Medicines used for sleeplessness and anxiety, such as triazolam or midazolam.
- Methylprednisolone used for inflammation
- Cilostazol used for intermittent cramp-like pain in your legs when you walk caused by insufficient blood supply in your legs.
getting side effects. If you are concerned you should stop drinking grapefruit juice and consult your doctor.
Tildiem LA may make the following medicine work less well:
- Rifampicin used for tuberculosis.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The following medicines can increase the effect of Tildiem LA:
- Medicines for stomach ulcers such as cimetidine and ranitidine.
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.
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 2
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 contains Sodium: This medicine contains less than 1 mmol sodium (23 mg) per daily dose, that is to say essentially "sodium free". Driving and using machines
You may feel dizzy while taking this medicine. If this happens, do not drive or use any tools or machines.
How to take it
Tildiem LA
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Other medicines and Tildiem LA
Children and adolescents 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, decrease of kidney function, coma, and sudden death. If you take more Tildiem LA than you should contact your doctor or nearest hospital straight away:
- 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 the only 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.
- 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 of your feet. These could be signs of a serious allergy to the medicine called 'erythema multiforme'.
Possible side effects
Common (affects less than 1 in 10 people)
- Slow or uneven heartbeat
- Very fast, uneven or forceful heartbeat (palpitations)
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 (cannot be estimated from the available data)
- 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 in swallowing.
- Your asthma gets worse.
- You have difficulty breathing, wheezing, tightness in the chest (called 'bronchospasm'). 3
Tell your doctor straight away if you notice any of the following serious side effects
- you may need urgent medical treatment:
Frequency unknown (cannot be estimated from the available data)
- 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').
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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 Tildiem LA 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.
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 (cannot be estimated from the available data)
- 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 (cannot be estimated from the available data)
- Mood changes, including depression
- Bleeding or bruising under the skin
- 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) Blood tests Tildiem LA 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. 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.
How to store it
Tildiem LA 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 after 'EXP'. The expiry date refers to the last day of that month. Store below 25°C 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 protect the environment.
Contents of the pack and other information
What Tildiem LA contains
- Each Tildiem LA 200mg capsule contains 200mg of the active substance diltiazem hydrochloride. 4
Each Tildiem LA 300mg capsule contains 300mg of the active substance diltiazem hydrochloride.
- The other ingredients are microcrystalline cellulose, carmellose sodium, acrylic and methacrylic esters copolymer, ethylcellulose, diacetylated monoglycerides, magnesium stearate, gelatin, and titanium dioxide (E171). Tildiem LA 200mg capsules also contains red iron oxide (E172) and black iron oxide (E172). Tildiem LA 300mg capsules also contains yellow iron oxide (E172). What Tildiem LA look like and contents of the pack Tildiem LA 200mg capsules are opaque capsules with a grey body and pink cap. Tildiem LA 300mg capsules are supplied as opaque capsules with a white body and yellow cap. The capsules are provided in blister packs containing 7 or 28 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sanofi 410 Thames Valley Park Drive Reading, Berkshire, RG6 1PT UK Tel: 0800 035 2525 Email: [email protected] Manufacturer Sanofi Winthrop Industrie 30-36 avenue Gustave Eiffel, 37000 Tours France This leaflet does not contain all the information about your medicine. If you have any further questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in September 2024 © Sanofi, 1991-2024 925430
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- Passing large amounts of urine, excessive thirst and having a dry mouth or skin. These may be signs of high blood sugar (hyperglycaemia).
- Get sunburnt easier, and which may be more severe than in someone not taking Tildiem LA. You should use sun protection whilst taking this medicine.
- Breast enlargement in men
Frequently asked questions about Tildiem LA 300mg Prolonged-Release Capsules
How do I take Tildiem LA 300mg Prolonged-Release Capsules?
Tildiem LA 300mg Prolonged-Release Capsules comes as capsule containing 300mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Tildiem LA 300mg Prolonged-Release Capsules?
The active substance in Tildiem LA 300mg Prolonged-Release Capsules is diltiazem hydrochloride.
Are there equivalent medicines to Tildiem LA 300mg Prolonged-Release Capsules?
Medicines with the same active substance, strength and form include: ADIZEM-XL capsules 300 mg, Slozem 300mg Capsules, Slozem 300mg Capsules. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Tildiem LA 300mg Prolonged-Release Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Tildiem LA 300mg Prolonged-Release Capsules without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: diltiazem hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Mild to moderate hypertension and angina pectoris.
4.2. Posology and method of administration
Tildiem LA 300 is a prolonged release product for once daily dosing. The capsules should not be crushed or chewed but swallowed whole with water, ideally before or during a meal. The dosage requirements may differ in patients with angina or hypertension.
Tildiem (diltiazem hydrochloride) is available in a range of presentations to enable dosage to be adjusted to meet the individual requirements of the patient. Careful titration of the dose should be considered where appropriate, as individual patient response may vary. When changing from one type of Tildiem formulation to another it may be necessary to adjust the dosage until a satisfactory response is obtained. To ensure consistency of response once established, particularly in the prolonged release formulations, Tildiem LA 200 and 300 should continue to be prescribed by brand name.
Adults
Angina and hypertension
The usual starting dose is Tildiem LA 200 once daily. This dose may be increased to Tildiem LA 300 once daily, or 2 capsules of Tildiem LA 200 daily (400 mg), and if clinically indicated a higher dose of one Tildiem LA 300 plus one Tildiem LA 200 capsule (total 500 mg) may be considered.
Elderly and patients with impaired hepatic or renal function
Heart rate should be monitored and if it falls below 50 beats per minute the dose should not be increased. Plasma levels of diltiazem can be increased in this group of patients.
Angina and hypertension
The initial dose should be one Tildiem LA 200 capsule daily. This dose may be increased to one capsule of Tildiem LA 300 daily, if clinically indicated.
Paediatric population
Safety and efficacy in children have not been established. Therefore, diltiazem is not recommended for use in children.
4.3. Contraindications
• Hypersensitivity to diltiazem or to any of the excipients listed in section 6.1.
• Sick sinus syndrome, 2nd or 3rd degree AV block in patients without a functioning pacemaker.
• Severe bradycardia (less than 50 beats per minute).
• Left ventricular failure with pulmonary stasis.
• Lactation.
• Concurrent use with dantrolene infusion (see section 4.5).
• Combination with ivabradine (see section 4.5).
• Concurrent use with lomitapide (see section 4.5).
• Concurrent use with asunaprevir (see section 4.5).
4.4. Special warnings and precautions for use
Close observation is necessary in patients with reduced left ventricular function, bradycardia (risk of exacerbation) or with a 1st degree AV block or prolonged PR interval detected on the electrocardiogram (risk of exacerbation and rarely, of complete block).
Increase of plasma concentrations of diltiazem may be observed in the elderly and patients with renal or hepatic insufficiency. The contraindications and precautions should be carefully observed and close monitoring, particularly of heart rate, should be carried out at the beginning of treatment.
Cases of acute renal failure secondary to decreased renal perfusion have been reported in patients with existing cardiac disease especially reduced left ventricular function, severe bradycardia or severe hypotension. Careful monitoring of renal function is advised.
In the case of general anaesthesia, the anaesthetist must be informed that the patient is taking diltiazem. The depression of cardiac contractility, conductivity and automaticity as well as the vascular dilatation associated with anaesthetics may be potentiated by calcium channel blockers.
Treatment with diltiazem may be associated with mood changes, including depression (see section 4.5 and 4.8). Early recognition of relevant symptoms is important, especially in predisposed patients. In such cases, drug discontinuation should be considered.
Diltiazem has an inhibitory effect on intestinal motility. Therefore, it should be used with caution in patients at risk of developing an intestinal obstruction.
Careful monitoring is necessary in patients with latent or manifest diabetes mellitus due to a possible increase in blood glucose.
The use of diltiazem may induce bronchospasm, including asthma aggravation, especially in patients with preexisting bronchial hyper-reactivity. Cases have also been reported after dose increase. Patients should be monitored for signs and symptoms of respiratory impairment during diltiazem therapy.
This medicine contains less than 1 mmol sodium (23 mg) per capsule that is to say essentially 'sodium-free'.
Caution should be exercised when direct oral anticoagulants (DOACs) are co-administered with Diltiazem which is a moderate CYP3A4 and a weak P-gp inhibitor, particularly in patients at high risk of bleeding (see Interactions).
4.5. Interaction with other medicinal products and other forms of interaction
Combination Contraindicated for Safety Reasons
Dantrolene (infusion)
Lethal ventricular fibrillation is regularly observed in animals when intravenous verapamil and dantrolene are administered concomitantly.
The combination of a calcium antagonist and dantrolene is therefore potentially dangerous (see section 4.3).
Ivabradine
Concomitant use with ivabradine is contraindicated due to the additional heart rate lowering effect of diltiazem to ivabradine (see section 4.3).
Lomitapide
Diltiazem (a moderate CYP3A4 inhibitor) may increase lomitapide plasma concentrations through CYP3A4 inhibition leading to increased risk of elevations in liver enzymes (see section 4.3).
Asunaprevir
Diltiazem (a moderate CYP3A4 inhibitor) may increase asunaprevir plasma concentrations through CYP3A4 inhibition (see section 4.3).
Combinations Requiring Caution
Alpha-antagonists
Increased anti-hypertensive effects. Concomitant treatment with alpha- antagonists may produce or aggravate hypotension. The combination of diltiazem with an alpha antagonist should be considered only with strict monitoring of blood pressure.
Beta-blockers
Possibility of rhythm disturbances (pronounced bradycardia, sinus arrest), sino-atrial and atrio-ventricular conduction disturbances and heart failure (synergistic effect).
Such a combination must only be used under close clinical and ECG monitoring, particularly at the beginning of treatment.
An increased risk of depression has been reported when diltiazem is co-administered with beta-blockers (see section 4.8).
Amiodarone, Digoxin
Increased risk of bradycardia; caution is required when these are combined with diltiazem, particularly in elderly subjects and when high doses are used.
Antiarrhythmic agents
Since diltiazem has antiarrhythmic properties, its concomitant prescription with other antiarrhythmic agents is not recommended due to the risk of increased cardiac adverse effects due to an additive effect. This combination should only be used under close clinical and ECG monitoring.
Nitrate derivatives
Increased hypotensive effects and faintness (additive vasodilation effects).
In all patients treated with calcium antagonists, the prescription of nitrate derivatives should only be carried out at gradually increasing doses.
Ciclosporin
Increase in circulating ciclosporin levels. It is recommended that the ciclosporin dose be reduced, renal function be monitored, circulating ciclosporin levels be assayed and that the dose should be adjusted during combined therapy and after its discontinuation.
Phenytoin
When co-administered with phenytoin, diltiazem may increase phenytoin plasma concentration. It is recommended that the phenytoin plasma concentrations be monitored.
X-Ray Contrast Media
Cardiovascular effects of an intravenous bolus of an ionic X-ray contrast media, such as hypotension, may be increased in patients treated with diltiazem.
Special caution is required in patients who concomitantly receive diltiazem and X-ray contrast media.
Carbamazepine
Increase in circulating carbamazepine levels. It is recommended that the plasma carbamazepine concentrations be assayed and that the dose should be adjusted if necessary.
Theophylline
Increase in circulating theophylline levels.
Anti-H2 agents (cimetidine and ranitidine)
Increase in plasma diltiazem concentrations. Patients currently receiving diltiazem therapy should be carefully monitored when initiating or discontinuing therapy with anti-H2 agents. An adjustment in diltiazem daily dose may be necessary.
Rifampicin
Risk of decrease of diltiazem plasma levels after initiating therapy with rifampicin. The patient should be carefully monitored when initiating or discontinuing rifampicin treatment.
Lithium
Risk of increase in lithium-induced neurotoxicity.
Antiplatelet drugs
In a pharmacodynamic study, diltiazem was shown to inhibit platelet aggregation. Although the clinical significance of this finding is unknown, potential additive effects when used with antiplatelet drugs should be considered.
Combinations to be Taken into Account:
Diltiazem is metabolised by CYP3A4. A moderate (less than 2-fold) increase of diltiazem plasma concentration in cases of co-administration with a stronger CYP3A4 inhibitor has been documented. Grapefruit juice may increase diltiazem exposure (1.2-fold). Patients who consume grapefruit juice should be monitored for increased adverse effects of diltiazem. Grapefruit juice should be avoided if an interaction is suspected. Diltiazem is also a CYP3A4 isoform inhibitor. Co-administration with other CYP3A4 substrates may result in an increase in plasma concentration of either co-administered drug. Co-administration of diltiazem with a CYP3A4 inducer may result in a decrease of diltiazem plasma concentrations.
Statins
Diltiazem is an inhibitor of CYP3A4 and has been shown to significantly increase the AUC of some statins. The risk of myopathy and rhabdomyolysis is increased by concomitant administration of diltiazem with statins metabolised by CYP3A4 (e.g. atorvastatin, fluvastatin, and simvastatin). An adjustment of the dose of statin may be necessary (see also product information of the relevant statin). When possible, it is recommended to use a statin not metabolised by CYP3A4 (e.g. pravastatin) with diltiazem.
Cilostazol
Inhibition of cilostazol metabolism (CYP3A4). Diltiazem has been shown to increase cilostazol exposure and to enhance its pharmacological activity.
Benzodiazepines (midazolam, triazolam)
Diltiazem significantly increases plasma concentrations of midazolam and triazolam and prolongs their half-life. Special care should be taken when prescribing short-acting benzodiazepines metabolised by the CYP3A4 pathway in patients using diltiazem.
Corticosteroids (methylprednisolone)
Diltiazem can increase methylprednisolone levels (through inhibition of CYP3A4 and possible inhibition of P-glycoprotein). The patient should be monitored when initiating methylprednisolone treatment. An adjustment to the dose of methylprednisolone may be necessary.
Colchicine
Colchicine is a substrate for both CYP3A and the efflux transporter P-glycoprotein (P-gp). Diltiazem is known to inhibit CYP3A and P-gp. When Diltiazem and colchicine are administered together, inhibition of P-gp and/or CYP3A by Diltiazem may lead to increased exposure to colchicine. Combined use is not recommended.
Diltiazem which is a moderate CYP3A4 and weak P-gp inhibitor may increase the plasma concentration of DOACs when co-administered with Diltiazem.
Diltiazem may lead to QT prolongation, when administered with drugs with potential/ known for prolonging the QT interval. Co-administration of diltiazem with drugs known to prolong the QT interval must be based on a careful assessment of the potential risks and benefits of the treatment.
General Information to be Taken into Account:
Due to the potential for additive effects, caution and careful titration are necessary in patients receiving diltiazem concomitantly with other agents known to affect cardiac contractility and/or conduction.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is very limited data from the use of diltiazem in pregnant patients. Diltiazem has been shown to have reproductive toxicity (see section 5.3) in certain animal species (rat, mice, rabbit). Diltiazem is therefore not recommended during pregnancy, as well as in women of child-bearing potential not using effective contraception.
Breast-feeding
As this drug is excreted in breast milk, breast feeding whilst taking diltiazem is contraindicated.
4.7. Effects on ability to drive and use machines
On the basis of reported adverse drug reactions, i.e. dizziness (common), malaise (common), the ability to drive and use machines could be altered. However, no studies have been performed.
4.8. Undesirable effects
The following CIOMS frequency rating is used, when applicable: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to ≤ 1/100); rare (≥ 1/10,000 to ≤ 1/1,000); very rare (≤ 1/10,000); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
Very Common
Common
Uncommon
Rare
Not known
Blood and lymphatic system disorders
Thrombocytopenia
Psychiatric disorders
Nervousness, insomnia
Mood changes including depression
Nervous system disorders
Headache, dizziness
Extrapyramidal syndrome
Respiratory, thoracic and mediastinal disorders
Bronchospasm (including asthma aggravation)
Cardiac disorders
Atrioventricular block (may be of first, second or third degree; bundle branch block may occur), palpitations
Bradycardia
Sinoatrial block, congestive heart failure sinus arrest, cardiac arrest (asystole)
Vascular disorders
Flushing
Orthostatic hypotension
Vasculitis (including leukocytoclastic vasculitis)
Gastrointestinal disorders
Constipation, dyspepsia, gastric pain, nausea
Vomiting, diarrhea
Dry mouth
Gingival hyperplasia
Metabolism and nutrition disorders
Hyperglycemia
Hepatobiliary disorders
Hepatic enzymes increase (AST, ALT, LDH, ALP increase)
Hepatitis
Skin and subcutaneous tissue disorders
Erythema
Urticaria
Photosensitivity (including lichenoid keratosis at sun exposed skin areas), angioneurotic oedema, rash, erythema multiforme (including Steven-Johnson's syndrome and toxic epidermal necrolysis), sweating, exfoliative dermatitis, acute generalized exanthematous pustulosis, occasionally desquamative erythema with or without fever, Lupus-like syndrome, Lichenoid drug eruption
Reproductive system and breast disorders
Gynecomastia
General disorders and administration site conditions
Peripheral oedema
Malaise
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
The clinical effects of acute overdose can involve pronounced hypotension leading to collapse and acute kidney injury, sinus bradycardia with or without isorhythmic dissociation, sinus arrest, atrioventricular conduction disturbances and cardiac arrest.
Non-cardiogenic pulmonary oedema has rarely been reported as a consequence of diltiazem overdose that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Early resuscitative measures (including fluid overload) to maintain perfusion and cardiac output may be precipitating factors.
Treatment, under hospital supervision, will include gastric lavage, osmotic diuresis. Conduction disturbances may be managed by temporary cardiac pacing.
Proposed corrective treatments: atropine, vasopressors, inotropic agents, glucagon and calcium gluconate infusion.
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Ask anything about Tildiem LA 300mg Prolonged-Release Capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Diltiazem hydrochloride
- ADIZEM-SR capsules 120 mg
- ADIZEM-SR capsules 180 mg
- ADIZEM-SR capsules 90 mg
- ADIZEM-XL capsules 180 mg
- ADIZEM-XL capsules 200 mg
- ADIZEM-XL capsules 120 mg
- ADIZEM-XL capsules 240 mg
- ADIZEM-XL capsules 300 mg
- Angitil SR/XL Capsules
- Slozem 120mg Capsules
- Slozem 180mg Capsules
- Slozem 240mg Capsules
- Slozem 300mg Capsules
- Tildiem 60mg Modified-Release Tablets