Dilzem 180 retard

Package leaflet: Information for the user

Dilzem 180 Retard, 180 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 as 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 someone else 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.

Contents of the leaflet:

1. What Dilzem 180 Retard is and what it is used for
2. What you need to know before taking Dilzem 180 Retard
3. How to take Dilzem 180 Retard
4. Possible side effects
5. How to store Dilzem 180 Retard
6. Contents of the pack and other information

1. What Dilzem 180 Retard is and what it is used for

Dilzem 180 Retard belongs to a group of medicines called calcium antagonists. These medicines act on smooth vascular muscles and also have a strong effect on the heart muscle. Dilzem 180 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 180 Retard

When not to use Dilzem 180 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 (heart rate less than 40 beats per minute);
• in patients with left ventricular failure accompanied by 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 180 Retard and other medicines").

Warnings and precautions
Before starting treatment with Dilzem 180 Retard, consult your doctor or pharmacist:

• caution is required in patients with left ventricular dysfunction, bradycardia, or first-degree atrioventricular block;
• in the case of general anaesthesia, inform the anaesthetist about the use of Dilzem 180 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, such patients should remain under close medical supervision, particularly regarding heart rate monitoring;
• caution is advised in patients at risk of intestinal obstruction, as Dilzem 180 Retard may reduce gastrointestinal motility. Intact 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, slow heart rate, or low blood pressure. Since cases of renal impairment have been reported in patients with such conditions, the doctor may recommend monitoring of kidney function.

Treatment with Dilzem 180 Retard may be associated with mood changes, including depression.

Dilzem 180 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 180 Retard may increase the risk of lithium neurotoxicity;
• nitrates – concomitant use with Dilzem 180 Retard may enhance hypotensive effects and increase the risk of fainting (due to vasodilatory action);
• theophylline – concomitant use with Dilzem 180 Retard may increase theophylline blood levels;
• alpha-adrenergic receptor blockers – concomitant use with Dilzem 180 Retard and alpha-adrenergic receptor antagonists may cause or exacerbate hypotension; therefore, this combination should only be considered under strict monitoring of arterial pressure;
• amiodarone, digoxin – concomitant use with Dilzem 180 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 180 Retard may lead to cardiac rhythm disturbances (marked bradycardia, sinus arrest), disturbances in sinoatrial and atrioventricular conduction, and heart failure;
• other antiarrhythmic drugs – concomitant use with Dilzem 180 Retard may increase the risk of additional cardiac adverse effects;
• carbamazepine – concomitant use with Dilzem 180 Retard may increase carbamazepine blood levels;
• rifampicin – concomitant use with Dilzem 180 Retard may reduce plasma concentrations of diltiazem hydrochloride;
• cimetidine, ranitidine – concomitant use with Dilzem 180 Retard may increase plasma concentrations of diltiazem;
• cyclosporine – concomitant use with Dilzem 180 Retard may increase blood levels of cyclosporine; therefore, in combined treatment, it is recommended to reduce the cyclosporine dose, monitor kidney 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 concentration, which may lead to an increased likelihood and severity of liver-related adverse effects.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The use of Dilzem 180 Retard is contraindicated during pregnancy and in women of childbearing potential who are not using effective contraception. If treatment with Dilzem 180 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 180 Retard contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Dilzem 180 Retard

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult your doctor or pharmacist.
Taking Dilzem 180 Retard with food and drink
The tablets should be taken before meals, without chewing, and swallowed with sufficient fluid
(e.g. one glass of water).
Ischaemic heart disease
Half a tablet of Dilzem 180 Retard twice daily (corresponding to 2 x 90 mg diltiazem hydrochloride per day). If necessary, the doctor may increase the dose to 360 mg per day (one retard tablet in the morning and one retard tablet in the evening). The daily dose should not exceed 360 mg. In cases of long-term treatment with satisfactory clinical effect, the doctor may check every 2–3 months whether a reduction in dose is possible.
Arterial hypertension
1 tablet of Dilzem 180 Retard per day (corresponding to 180 mg diltiazem hydrochloride per day), taken in the morning. If necessary, the doctor may increase the dose up to the maximum daily dose of 360 mg (one Dilzem 180 Retard tablet in the morning and one Dilzem 180 Retard tablet in the evening). Doses exceeding the maximum daily dose should not be used. If a satisfactory antihypertensive effect is achieved, the doctor may consider reducing the dose.
Use of Dilzem 180 Retard in patients with renal or hepatic impairment
Dilzem 180 Retard must be used with caution in patients with impaired kidney or liver function.
Use of Dilzem 180 Retard in elderly patients
Dilzem 180 Retard must be used with caution in elderly patients.
Taking more Dilzem 180 Retard than recommended
Overdosing with Dilzem 180 Retard may lead to severe hypotension, including shock, bradycardia (reduced heart rate), heart failure, atrioventricular block, or impaired kidney function.
If more Dilzem 180 Retard has been taken than recommended, contact a doctor immediately. Depending on the symptoms present, the doctor will initiate appropriate treatment.
If you forget to take Dilzem 180 Retard
If a patient forgets to take Dilzem 180 Retard, they should take it as soon as possible, unless it is almost 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 a missed dose.
Duration of treatment
Dilzem 180 Retard is intended for long-term treatment. Discontinuation or dose adjustment should only be performed under a doctor's instruction.
Stopping Dilzem 180 Retard
If treatment with Dilzem 180 Retard is to be discontinued, the medicine should be withdrawn gradually by reducing the dose stepwise, especially in patients with ischaemic heart disease.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of adverse reactions is presented according to the MedDRA convention: 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);
frequency not known (cannot be estimated from the available data).

Blood and lymphatic system disorders:
Frequency not known: thrombocytopenia

Psychiatric disorders:
Uncommon: nervousness, insomnia
Frequency not known: mood changes (including depression)

Nervous system disorders:
Common: headache, dizziness
Frequency not known: extrapyramidal symptoms, myoclonus (muscle jerks)

Cardiac disorders:
Common: atrioventricular block (first-, second-, or third-degree, including possible bundle branch block), palpitations
Uncommon: bradycardia (reduced heart rate)
Frequency not known: sinoatrial block, congestive heart failure

Vascular disorders:
Common: flushing, especially of the face
Uncommon: orthostatic hypotension
Frequency not known: vasculitis (including leukocytoclastic vasculitis)

Gastrointestinal disorders:
Common: constipation, dyspepsia, stomach pain, nausea
Uncommon: vomiting, diarrhoea
Rare: dryness of the oral mucosa
Frequency not known: gingival hyperplasia

Hepatobiliary disorders:
Uncommon: increased liver enzyme activity (AspAT, AlAT, LDH, alkaline phosphatase)
Frequency not known: hepatitis

Skin and subcutaneous tissue disorders:
Common: rash
Rare: urticaria
Frequency not known: photosensitivity (including lichenoid cutaneous keratosis in sun-exposed skin), angioedema, rash, erythema multiforme (including Stevens-Johnson syndrome and toxic epidermal necrolysis), sweating, exfoliative dermatitis, acute generalized exanthematous pustulosis, rare desquamative erythema with or without fever, a condition in which the immune system attacks normal tissues, causing symptoms such as joint swelling, fatigue and rash (known as "lupus-like syndrome")

Reproductive system and breast disorders:
Frequency not known: gynaecomastia

General disorders and administration site conditions:
Very common: peripheral oedema
Common: malaise

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 the representative of the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dilzem 180 Retard

The medicine should be stored in a place inaccessible and not visible to children.
No special storage precautions are required.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date (EXP) refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Dilzem 180 Retard contains

• The active substance is diltiazem (in the form of diltiazem hydrochloride).
• The other ingredients are: lactose monohydrate, hydrogenated castor oil, stearic acid, hydroxyethylcellulose, magnesium stearate, hypromellose, titanium dioxide, talc, macrogol 6000, polydimethylsiloxane.

What Dilzem 180 Retard looks like and contents of the pack
Dilzem 180 Retard – white, oval film-coated tablets with a score line on both sides.
The pack contains 30 tablets.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Manufacturer
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany

For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Pfizer Polska Sp. z o.o.
tel. 22 335 61 00

Detailed and up-to-date information on this 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-dilzem180retard and on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: http://www.urpl.gov.pl