Dilzem retard

Leaflet attached to the packaging: information for the user

Dilzem Retard, 90 mg, prolonged-release tablets

Diltiazem hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Dilzem Retard and what is it used for
• 2. Important information before taking Dilzem Retard
• 3. How to take Dilzem Retard
• 4. Possible side effects
• 5. How to store Dilzem Retard
• 6. Contents of the pack and other information

1. What is Dilzem Retard and what is it used for

Dilzem Retard belongs to a group of medicines called calcium antagonists. These medicines act on the smooth muscles of blood vessels and have a strong effect on the heart muscle. Dilzem Retard is indicated for the treatment of:

• ischaemic heart disease in the form of:
• stable angina pectoris
• unstable angina pectoris
• vasospastic angina pectoris (Prinzmetal's variant)
• hypertension.

2. Important information before taking Dilzem Retard

When not to take Dilzem Retard

• if you are allergic to diltiazem hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• in patients with sick sinus syndrome, except in patients with a functioning artificial pacemaker;
• in patients with second or third degree atrioventricular block, except in patients with a functioning artificial pacemaker;
• in patients with severe bradycardia (less than 40 beats per minute);
• in patients with left ventricular failure with pulmonary congestion;
• in patients receiving intravenous dantrolene;
• in patients receiving ivabradine-containing medicines for the treatment of certain heart conditions;
• in patients receiving lomitapide-containing medicines for the treatment of high cholesterol levels (see section "Dilzem Retard and other medicines").

Warnings and precautions

Before taking Dilzem Retard, discuss it with your doctor or pharmacist:

• in case of left ventricular dysfunction, bradycardia or first-degree atrioventricular block, caution should be exercised;
• in case of general anaesthesia, the doctor should be informed about the use of Dilzem Retard, as it may enhance the effects of anaesthetics on contractility, conduction and automaticity of the heart, as well as the vasodilatory effect of anaesthetics;
• in elderly patients and patients with renal or hepatic impairment, it is possible to increase the concentration of diltiazem in the blood, so patients should remain under close medical supervision; in particular, heart rate should be monitored frequently;
• in patients at risk of intestinal obstruction, caution should be exercised, as Dilzem Retard inhibits gastrointestinal motility. Residues of the product in the form of prolonged-release tablets may appear in the patient's stool; however, this has no clinical significance;
• if the patient has a history of heart failure, new symptoms of shortness of breath, slow heart rate or low blood pressure have occurred. Since cases of kidney damage have been reported in patients with these conditions, the doctor may recommend monitoring kidney function.

Taking Dilzem Retard may be associated with mood changes, including depression.

Dilzem Retard and other medicines

Dilzem Retard may enhance the effects of other medicines taken at the same time.
Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

• lithium - concomitant use with Dilzem Retard may increase the risk of lithium neurotoxicity;
• nitrates - concomitant use with Dilzem Retard may increase the hypotensive effect and the risk of syncope (vasodilatory effect);
• theophylline - concomitant use with Dilzem Retard may increase theophylline levels in the blood;
• alpha-adrenergic receptor blockers - concomitant use of alpha-adrenergic receptor blockers with Dilzem Retard may cause or increase hypotension, so the use of this combination can only be considered under close monitoring of blood pressure;
• amiodarone, digoxin - concomitant use with Dilzem Retard may increase the risk of bradycardia, so caution should be exercised during treatment, especially in elderly patients and in case of high doses;
• beta-adrenergic receptor blockers: concomitant use with Dilzem Retard may cause cardiac rhythm disturbances (marked bradycardia, sinoatrial block), atrioventricular conduction disturbances and heart failure;
• other antiarrhythmic medicines - concomitant use with Dilzem Retard may increase the risk of cardiac side effects;
• carbamazepine - concomitant use with Dilzem Retard may increase carbamazepine levels in the blood;
• rifampicin - concomitant use with Dilzem Retard may increase the risk of decreased diltiazem hydrochloride levels in the blood;
• cimetidine, ranitidine - concomitant use with Dilzem Retard may increase diltiazem levels in the blood;
• cyclosporin - concomitant use with Dilzem Retard may increase cyclosporin levels in the blood, so in case of combined treatment, it is recommended to reduce the dose of cyclosporin, monitor kidney function, control cyclosporin levels in the blood and adjust the dose;
• immunosuppressive agents (sirolimus, temsirolimus, everolimus);
• medicines containing lomitapide used to treat high cholesterol levels. Diltiazem may increase lomitapide levels, which may lead to an increased risk of liver-related side effects.

Taking Dilzem Retard with food and drink

Tablets should be taken whole, before meals, with a sufficient amount of liquid (e.g. one glass of water).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Taking Dilzem Retard is contraindicated during pregnancy, as well as in women of childbearing age not using effective contraception methods. In case of necessity to take Dilzem Retard during breastfeeding, an alternative method of feeding the baby should be used.

Driving and using machines

Based on the collected adverse reactions, i.e. dizziness (frequent), malaise (frequent), the ability to drive and use machines may be impaired, but no studies have been conducted.

Dilzem Retard contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

Dilzem Retard contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, i.e. the medicine is considered "sodium-free".

3. How to take Dilzem Retard

This medicine should be taken as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
The following dosing schedule is recommended for adults.
Ischaemic heart disease
Twice a day 1 tablet of Dilzem Retard (corresponding to 180 mg of diltiazem hydrochloride per day).
If necessary, the dose of the medicine may be increased to 360 mg per day. In case of long-term treatment with a satisfactory clinical effect, it is recommended to check every 2-3 months whether it is possible to reduce the dose of the medicine.
Hypertension
Twice a day 1 prolonged-release tablet of Dilzem Retard (corresponding to 180 mg of diltiazem hydrochloride per day).
If necessary, the dose of the medicine may be increased to a maximum dose of 360 mg per day.
In case of a satisfactory antihypertensive effect, the doctor may consider reducing the dose of the medicine.

Taking Dilzem Retard in patients with renal or hepatic impairment

Dilzem Retard should be used with caution in patients with renal or hepatic impairment.

Taking Dilzem Retard in children and adolescents

Data on the safety of use in this patient group have not been evaluated.

Taking Dilzem Retard in elderly patients

Dilzem Retard should be used with caution in elderly patients.

Taking a higher dose of Dilzem Retard than recommended

Overdose of Dilzem Retard may lead to severe hypotension, including shock, bradycardia (decreased heart rate), heart failure, atrioventricular block or renal dysfunction.
In case of taking a higher dose of Dilzem Retard than recommended, you should immediately contact your doctor. Depending on the symptoms, the doctor will apply appropriate treatment.

Missing a dose of Dilzem Retard

In case you miss a dose of Dilzem Retard, you should take it as soon as possible, unless it is almost time for the next dose. In this case, you should take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Duration of treatment

Dilzem Retard is used for long-term treatment. Discontinuation of treatment or changes in the dosing of the medicine should only be done under medical supervision.

Stopping treatment with Dilzem Retard

If treatment with Dilzem Retard is to be discontinued, the medicine should be gradually withdrawn, reducing the subsequent doses, especially in patients with ischaemic heart disease.
If you have any further questions about 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.

Stop taking Dilzem Retard and contact your doctor immediately if you experience any of the following symptoms:

• swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing (angioedema) of unknown frequency.
• severe allergic reaction with skin rash, usually in the form of blisters or ulcers in the mouth and eyes, as well as other mucous membranes, e.g. genital organs (Stevens-Johnson syndrome) of unknown frequency.
• severe, widespread skin damage (exfoliative dermatitis) of unknown frequency.

Other side effects:

Very common (may affect more than 1 in 10 people)

• Peripheral oedema

Common (may affect up to 1 in 10 people)

• Headache, dizziness
• Atrioventricular block (a type of arrhythmia), palpitations, slow heart rate (bradycardia)
• Hot flushes
• Constipation, indigestion, abdominal pain, nausea
• Skin rash
• Joint swelling
• Lack of energy (asthenia), fatigue, malaise

Uncommon (may affect up to 1 in 100 people)

• Nervousness, insomnia
• Low blood pressure when standing up quickly, with or without dizziness (hypotension)
• Vomiting, diarrhoea
• Increased liver enzyme activity in the blood

Rare (may affect up to 1 in 1,000 people)

• Dry mouth
• Skin irritation and itching (urticaria)

Frequency not known (cannot be estimated from the available data)

• Decreased platelet count (thrombocytopenia)
• Decreased appetite, increased blood sugar levels (hyperglycaemia)
• Mood changes, including depression, disorientation, hallucinations, personality changes and sleep disturbances
• Motor disorders (extrapyramidal syndrome), memory loss (amnesia), sensation of tingling or burning (paresthesia), lethargy, drowsiness, transient loss of consciousness (syncope), tremors, sudden and involuntary muscle twitching
• Laziness of the eye (partial loss of vision in one or both eyes), eye irritation
• Ringing in the ears (tinnitus)

Disruption or change in the electrical signal in the heart (sinoatrial block, atrial arrest), difficulty in pumping blood in the heart (congestive heart failure), rapid heart rate (tachycardia), abnormal heart contractions (extrasystoles), irregular heartbeat (arrhythmia), chest pain or tightness (angina pectoris)

• Vasculitis
• Breathing difficulties (dyspnoea), nosebleeds, nasal congestion
• Gingivitis (gingival hyperplasia)
• Hepatitis (inflammatory liver disease), liver changes (granulomatous liver disease)
• Photosensitivity (hypersensitivity to light), erythema multiforme (a severe skin condition characterized by red patches and blisters), sweating, exfoliative dermatitis (redness of the skin, itching, hair loss) and acute generalized exanthematous pustulosis (sudden rash with accompanying fever, with the formation of pustules or changes on the skin surface, which are characterized by being small, inflamed, filled with pus and resembling blisters), small red spots on the skin (purpura), itching (pruritus)
• Joint pain, muscle pain
• Need to urinate at night (nocturia), frequent urination (polyuria)
• Breast enlargement in men (gynaecomastia), sexual dysfunction
• Difficulty walking
• Increased creatine phosphokinase (CPK) activity in blood tests, weight gain
• A condition in which the body's immune system attacks healthy tissue, causing symptoms such as joint inflammation, loss of energy and skin rashes (so-called lupus-like syndrome)

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Dilzem Retard

Keep this medicine out of the sight and reach of children.
No special storage requirements.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date (EXP) means the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dilzem Retard contains

• The active substance of the medicine is diltiazem hydrochloride. Each tablet contains 90 mg of diltiazem hydrochloride.
• The other ingredients are: lactose monohydrate (see section 2 "Dilzem Retard contains lactose monohydrate"), hydrogenated castor oil, stearic acid, sodium carmellose (see section 2 "Dilzem Retard contains sodium"), magnesium stearate, hypromellose, titanium dioxide, talc, macrogol 6000, silicone oil.

What Dilzem Retard looks like and contents of the pack

White, biconvex, round prolonged-release tablets.
30, 50 or 100 tablets in a cardboard box.

Marketing authorisation holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany
To obtain more detailed information, please contact the representative of the marketing authorisation holder:
Pfizer Polska Sp. z o.o.
tel. 22 335 61 00

Date of last revision of the leaflet: 11/2024

Detailed and up-to-date information about this product can be obtained by scanning the QR code on the outer packaging using a mobile device. The same information is also available at the URL: https://pfi.sr/ulotka-dilzemretard and on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
http://www.urpl.gov.pl .