Dilzem 120 retard

Patient Information Leaflet

Dilzem 120 retard, 120 mg, prolonged-release tablets
Diltiazemi hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 personally. 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, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Dilzem 120 retard is and what it is used for
2. What you need to know before you take 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 Dilzem 120 retard is and what it is used for

Dilzem 120 retard belongs to a group of medicines called calcium antagonists. These medicines act on vascular smooth muscle and also have a strong effect on the heart muscle. Dilzem 120 retard is indicated for the treatment of:

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

2. Important information before using Dilzem 120 retard

When not to use Dilzem 120 retard

• if the patient is 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 those with an implanted permanent ventricular pacemaker;
• in patients with second- or third-degree atrioventricular block, except in those with an implanted permanent ventricular pacemaker;
• in patients with severe bradycardia (less than 40 heartbeats per minute);
• in patients with left ventricular failure with pulmonary congestion;
• in patients receiving intravenous dantrolene;
• in patients taking medicines containing ivabradine, used in the treatment of certain heart conditions;
• in patients taking medicines containing lomitapide, used in the treatment of high cholesterol levels (see section: "Dilzem 120 retard and other medicines").

Warnings and precautions
Before starting treatment with Dilzem 120 retard, discuss this with your doctor or pharmacist:

• caution is required in case of impaired left ventricular function, bradycardia, or first-degree atrioventricular block;
• if general anaesthesia is required, inform the anaesthetist about taking Dilzem 120 retard, as it may enhance disturbances in myocardial contractility, conduction, and automaticity, as well as the vasodilatory effects of anaesthetic drugs;
• in elderly patients and in patients with renal or hepatic impairment, increased plasma concentrations of diltiazem may occur; therefore, patients should remain under close medical supervision, particularly regarding heart rate monitoring;
• caution is advised in patients at risk of intestinal obstruction, as Dilzem 120 retard inhibits gastrointestinal motility. Undissolved tablet shells from the extended-release formulation may appear in the patient's faeces; however, this has no clinical significance;
• if the patient has a history of heart failure and develops new symptoms such as dyspnoea, slowed heart rate, or low blood pressure, renal function should be monitored, as cases of renal impairment have been reported in such patients.

Treatment with Dilzem 120 retard may be associated with mood changes, including depression.
Dilzem 120 retard and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use.

• lithium – concomitant use with Dilzem 120 retard may increase the risk of lithium neurotoxicity;
• nitrates – concomitant use with Dilzem 120 retard may enhance hypotensive effects and increase the risk of fainting (vasodilatory effect);
• theophylline – concomitant use with Dilzem 120 retard may increase theophylline blood levels;
• alpha-adrenergic receptor blockers – concomitant use with Dilzem 120 retard may cause or exacerbate hypotension; therefore, such combination should only be considered under strict monitoring of arterial pressure;
• amiodarone, digoxin – concomitant use with Dilzem 120 retard may increase the risk of bradycardia; caution is therefore advised, especially in elderly patients and when high doses are used;
• beta-adrenergic receptor blockers – concomitant use with Dilzem 120 retard may cause cardiac rhythm disturbances (marked bradycardia, sinus arrest), disturbances in sinoatrial and atrioventricular conduction, and heart failure;
• other antiarrhythmic drugs – concomitant use with Dilzem 120 retard may increase the risk of additional cardiac adverse effects;
• carbamazepine – concomitant use with Dilzem 120 retard may increase carbamazepine blood levels;
• rifampicin – concomitant use with Dilzem 120 retard may reduce plasma concentrations of diltiazem hydrochloride;
• cimetidine, ranitidine – concomitant use with Dilzem 120 retard may increase plasma concentrations of diltiazem;
• cyclosporine – concomitant use with Dilzem 120 retard may increase blood levels of cyclosporine; therefore, in combined treatment, it is recommended to reduce the cyclosporine dose, monitor renal function, check cyclosporine blood levels, and adjust the dose accordingly;
• immunosuppressive drugs (sirolimus, temsirolimus, everolimus);
• medicines containing lomitapide used in the treatment of high cholesterol levels. Diltiazem may increase lomitapide levels, which may lead to an increased risk and severity of liver-related adverse effects.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The use of Dilzem 120 retard is contraindicated during pregnancy and in women of childbearing potential who are not using effective contraception. If treatment with Dilzem 120 retard is necessary during breastfeeding, an alternative method of infant feeding should be used.

Driving and operating machinery
Based on reported adverse effects such as dizziness (frequent) and malaise (frequent), the ability to drive or operate machinery may be impaired, although no specific studies have been conducted.

Dilzem 120 retard contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Dilzem 120 retard contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, meaning the medicine is considered "sodium-free".

3. How to use Dilzem 120 retard

This medicine should always be taken as directed by the physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Taking Dilzem 120 retard with food and drink
The tablets should be taken before meals, without chewing, and with sufficient fluid
(e.g. one glass of water).
Coronary heart disease
1 tablet of Dilzem 120 retard twice daily (corresponding to 240 mg of diltiazem hydrochloride per
day). If necessary, the physician may increase the dose to 360 mg per day. The daily dose
should not exceed 360 mg. In cases of long-term treatment with satisfactory clinical response,
the physician may evaluate every 2-3 months whether a dose reduction is possible.
Arterial hypertension
1 tablet of Dilzem 120 retard twice daily (corresponding to 240 mg of diltiazem hydrochloride per
day).
If necessary, the physician may increase the dose up to the maximum daily dose of 360 mg. Doses
higher than the maximum daily dose should not be used. If a satisfactory antihypertensive effect
is achieved, the physician may consider reducing the dose.
Use of Dilzem 120 retard in patients with renal or hepatic impairment
Dilzem 120 retard requires cautious use in patients with impaired kidney or liver function.
Use of Dilzem 120 retard in elderly patients
Dilzem 120 retard requires cautious use in elderly patients.
Taking more than the recommended dose of Dilzem 120 retard
Overdose of Dilzem 120 retard may lead to severe hypotension, including shock, bradycardia
(reduced heart rate), heart failure, atrioventricular block, or renal dysfunction.
If an overdose of Dilzem 120 retard has been taken, contact a physician immediately. Depending
on the symptoms present, the physician will initiate appropriate treatment.
Missed dose of Dilzem 120 retard
If a patient forgets to take Dilzem 120 retard, they should take it as soon as possible, unless it is
close to the time for the next dose. In that case, the patient should take the next dose at the
scheduled time. A double dose should not be taken to make up for the missed dose.
Duration of treatment
Dilzem 120 retard is used for long-term treatment. Discontinuation or dose adjustment should only
be performed under the direction of a physician.
Stopping Dilzem 120 retard
If treatment with Dilzem 120 retard is to be discontinued, the medicine should be tapered gradually
by reducing successive doses, especially in patients with coronary heart disease.
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking Dilzem 120 retard and contact your doctor immediately
if any of the following symptoms occur:

• Swelling of the face, tongue or throat, difficulty swallowing, skin rash and breathing difficulties (angioedema) with unknown frequency.
• Extremely 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) with unknown frequency.
• Severe, widespread skin damage (peeling of the epidermis and superficial mucous membranes) (toxic epidermal necrolysis) with unknown frequency.

Other adverse reactions:
Very common (may affect more than 1 in 10 people)

• Swelling of the legs

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, digestive difficulties (dyspepsia), abdominal pain, nausea
• Skin rash
• Joint swelling
• Lack of energy (asthenia), fatigue, malaise

Uncommon (may affect up to 1 in 100 people)

• Nervousness, difficulty sleeping (insomnia)
• Low blood pressure upon sudden standing, with or without dizziness (hypotension)
• Vomiting, diarrhoea
• Increased liver enzyme activity in blood

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

• Dryness of the oral mucosa
• Skin irritation and itching (urticaria)

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

• Decreased platelet count (thrombocytopenia)
• Decreased appetite, increased blood glucose levels (hyperglycaemia)
• Mood changes, including depression, disorientation, hallucinations, personality and sleep pattern changes
• Movement disorders (extrapyramidal syndrome), memory loss (amnesia), tingling or burning sensations (paraesthesiae), lethargy, drowsiness, transient loss of consciousness (fainting), tremor, sudden and involuntary twitching of a muscle or group of muscles
• Lazy eye (partial loss of vision in one or both eyes), eye irritation
• Ringing in the ears (tinnitus)
• Interruption or alteration of the electrical signal in the heart (sinus-atrial block, sinus arrest), difficulty in pumping blood by the heart (congestive heart failure), rapid heartbeat (tachycardia), irregular heartbeats (extrasystoles), irregular heartbeat (arrhythmia), pain or pressure in the chest (angina pectoris)
• Inflammation of blood vessels (vasculitis)
• Breathing difficulties (dyspnoea), nosebleeds, nasal mucosa congestion
• Inflammation of the gums (gingival hyperplasia)
• Inflammation of the liver (hepatitis), liver changes (granulomatous liver disease)
• Light sensitivity (photosensitivity), erythema multiforme (a severe skin disease characterized by red spots and blisters), sweating, exfoliative dermatitis (redness of the skin, itching, hair loss), and acute generalized exanthematous pustulosis (sudden rash accompanied by fever, with pustules or skin lesions that are small, purulent, pus-filled, and blister-like), small red spots on the skin (petechiae), itching (pruritus)
• Joint pain, muscle pain
• Need to urinate at night (nocturia), more 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 immune system attacks normal body tissue, causing symptoms such as joint inflammation, loss of energy and skin rashes (so-called lupus-like syndrome)

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions
not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse reactions can also be reported to the marketing authorisation holder or its representative.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dilzem 120 retard

Keep this medicine out of the sight and reach of children.
No special precautions for storage are required.
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 stated month.
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 protect the environment.

6. Contents of the pack and other information

What Dilzem 120 retard contains

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

What Dilzem 120 retard looks like and contents of the pack
Dilzem 120 retard – white, biconvex, round, film-coated tablets marked with “D 120” on one side.
Pack contains 30 tablets.

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

For further information, contact the Marketing Authorisation Holder’s representative:
Pfizer Polska Sp. z o.o.
tel. 22 335 61 00

Detailed and up-to-date information about this medicinal product can be obtained by scanning the QR code located on the outer packaging using a mobile device. The same information is also available at the following 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.