Dilzem 120 retard

Leaflet attached to the packaging: information for the user

Dilzem 120 retard, 120 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 those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Dilzem 120 retard and what is it used for
• 2. Important information before taking Dilzem 120 retard
• 3. How to take Dilzem 120 retard
• 4. Possible side effects
• 5. How to store Dilzem 120 retard
• 6. Contents of the pack and other information

1. What is Dilzem 120 retard and what is it used for

Dilzem 120 retard belongs to a group of medicines called calcium antagonists. These medicines act on the smooth muscle of blood vessels and have a strong effect on the heart muscle. Dilzem 120 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 120 retard

When not to take Dilzem 120 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 ventricular pacemaker;
• in patients with second or third degree atrioventricular block, except in patients with a functioning artificial ventricular pacemaker;
• in patients with severe bradycardia (less than 40 beats per minute);
• in patients with left ventricular failure with pulmonary congestion;
• in patients taking dantrolene intravenously;
• in patients taking medicines containing ivabradine, used to treat certain heart conditions;
• in patients taking medicines containing lomitapide, used to treat high cholesterol levels (see section "Dilzem 120 retard and other medicines").

Warnings and precautions

Before starting treatment with Dilzem 120 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 120 retard, as it may enhance the effects of anaesthetics on myocardial contractility, conduction and automaticity, as well as the vasodilating effect of anaesthetics;
• in case of 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 case of patients at risk of intestinal obstruction, caution should be exercised, as Dilzem 120 retard inhibits gastrointestinal motility. Residues of the product in the form of prolonged-release tablets may appear in the patient's faeces; 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. As renal impairment has been reported in patients with these conditions, the doctor may recommend monitoring renal function.

Taking Dilzem 120 retard may be associated with changes in mood, including depression.

Dilzem 120 retard and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take.

• lithium - concomitant use with Dilzem 120 retard may increase the risk of lithium neurotoxicity;
• nitrates - concomitant use with Dilzem 120 retard may increase the hypotensive effect and the risk of syncope (vasodilating effect);
• theophylline - concomitant use with Dilzem 120 retard may increase theophylline levels in the blood;
• alpha-adrenergic receptor blockers - concomitant use with Dilzem 120 retard may cause or exacerbate arterial hypotension, so the use of this combination can only be considered under close monitoring of blood pressure;
• amiodarone, digoxin - concomitant use with Dilzem 120 retard may increase the risk of bradycardia, so caution should be exercised, especially in elderly patients and when using high doses;
• beta-adrenergic receptor blockers: concomitant use with Dilzem 120 retard may cause cardiac rhythm disturbances (marked bradycardia, sinoatrial block), atrioventricular conduction disturbances and heart failure;
• other antiarrhythmic medicines - concomitant use with Dilzem 120 retard may increase the risk of cardiac side effects;
• carbamazepine - concomitant use with Dilzem 120 retard may increase carbamazepine levels in the blood;
• rifampicin - concomitant use with Dilzem 120 retard may increase the risk of decreased diltiazem hydrochloride levels in the blood;
• cimetidine, ranitidine - concomitant use with Dilzem 120 retard may increase diltiazem levels in the blood;
• cyclosporin - concomitant use with Dilzem 120 retard may increase cyclosporin levels in the blood, so in the case of combined treatment, it is recommended to reduce the dose of cyclosporin, monitor renal function, control cyclosporin levels in the blood and adjust the dose;

and

• immunosuppressants (sirolimus, temsirolimus, everolimus);
• medicines containing lomitapide, used to treat high cholesterol levels. Diltiazem may increase lomitapide levels, which may increase the likelihood and severity of liver-related side effects.

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. The use of Dilzem 120 retard is contraindicated during pregnancy, as well as in women of childbearing age who do not use effective contraception methods. In case of necessity to use Dilzem 120 retard in breastfeeding women, an alternative method of feeding the child should be used.

Driving and using machines

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

Dilzem 120 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 120 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 120 retard

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Taking Dilzem 120 retard with food and drink

Tablets should be taken before meals, without chewing, with a sufficient amount of liquid (e.g. one glass).
Ischaemic heart disease
Twice a day 1 tablet of Dilzem 120 retard (corresponding to 240 mg of diltiazem hydrochloride per day). If necessary, the doctor may increase the dose of the medicine to 360 mg per day. The daily dose should not exceed 360 mg. In the case of long-term treatment with a satisfactory clinical effect, every 2-3 months the doctor may check if it is possible to reduce the dose of the medicine.
Hypertension
Twice a day 1 tablet of Dilzem 120 retard (corresponding to 240 mg of diltiazem hydrochloride per day).
If necessary, the doctor may increase the dose of the medicine to a maximum of 360 mg per day. Do not take doses higher than the maximum daily dose. In case of a satisfactory antihypertensive effect, the doctor may consider reducing the dose of the medicine.

Taking Dilzem 120 retard in patients with renal or hepatic impairment

Dilzem 120 retard should be used with caution in patients with renal or hepatic impairment.

Taking Dilzem 120 retard in elderly patients

Dilzem 120 retard should be used with caution in elderly patients.

Taking a higher dose of Dilzem 120 retard than recommended

Overdose of Dilzem 120 retard may lead to severe hypotension, including shock, bradycardia (reduced heart rate), heart failure, atrioventricular block or renal dysfunction.
In case of taking a higher dose of Dilzem 120 retard than recommended, contact your doctor immediately. Depending on the symptoms, the doctor will apply appropriate treatment.

Missing a dose of Dilzem 120 retard

If you miss a dose of Dilzem 120 retard, take it as soon as possible, unless it is almost time for the next dose. In this case, 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 120 retard is used for long-term treatment. Stopping treatment or changing the dose of the medicine should only be done on the advice of a doctor.

Stopping treatment with Dilzem 120 retard

If treatment with Dilzem 120 retard is to be stopped, the medicine should be discontinued gradually, 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 120 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 (dyspepsia), 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)

• Dryness of the mucous membrane of the mouth
• Irritation and itching of the skin (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 and sleep pattern changes
• Movement disorders (extrapyramidal syndrome), memory loss (amnesia), sensation of tingling or burning (paraesthesia), lethargy, drowsiness, transient loss of consciousness (syncope), tremors, sudden and involuntary muscle twitching or muscle group twitching
• Laziness of the eye (partial loss of vision in one eye or both eyes), eye irritation
• Ringing in the ears (tinnitus)
• Disruption or change of 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 heart rate (arrhythmia), pain or pressure in the chest (angina pectoris)
• Vasculitis
• Breathing difficulties (dyspnoea), nosebleeds, nasal congestion
• Gingivitis (gingival hyperplasia)
• Hepatitis (inflammatory liver disease), changes in the liver (granulomatous liver disease)
• Sensitivity to light (photosensitivity), 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 (pollakiuria)
• 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 arthritis, loss of energy and skin rashes (so-called lupus-like syndrome)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Dilzem 120 retard

Keep the medicine out of the sight and reach of children.
No special precautions for storage are necessary.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dilzem 120 retard contains

• The active substance of the medicine is diltiazem (in the form of diltiazem hydrochloride). Each tablet contains 120 mg of diltiazem hydrochloride.
• The other ingredients are: lactose monohydrate (see section 2 "Dilzem 120 retard contains lactose monohydrate"), hydrogenated castor oil, stearic acid, sodium carmellose 300 (see section 2 "Dilzem 120 retard contains sodium"), magnesium stearate, hypromellose, titanium dioxide, talc, macrogol 6000, polydimethylsiloxane.

What Dilzem 120 retard looks like and contents of the pack

Dilzem 120 retard - white, biconvex, round film-coated tablets with the inscription "D 120" on one side.
The pack contains 30 tablets.

Marketing authorization 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 authorization 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-dilzem120retard and on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://www.urpl.gov.pl .