Dilzem 180 retard

Leaflet accompanying the packaging: information for the user

Dilzem 180 Retard, 180 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 inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

• 1. What is Dilzem 180 Retard and what is it used for
• 2. Important information 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 is Dilzem 180 Retard and what is it used for

Dilzem 180 Retard belongs to a group of medicines called calcium antagonists. These medicines have an effect on the smooth muscle of blood vessels and also have a strong effect on the heart muscle. Dilzem 180 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 angina)
• hypertension

2. Important information before taking Dilzem 180 Retard

When not to take Dilzem 180 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 those with a functioning artificial ventricular pacemaker;
• in patients with second or third degree atrioventricular block, except in those 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 receiving concomitant intravenous dantrolene;
• in patients receiving concomitant ivabradine, used to treat certain heart conditions;
• in patients receiving concomitant lomitapide, used to treat high cholesterol levels (see "Dilzem 180 Retard and other medicines").

Warnings and precautions

Before starting treatment with Dilzem 180 Retard, you should 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 180 Retard, as it may enhance the effects of anaesthetics on contractility, conduction and automaticity of the heart muscle, as well as the vasodilatory effect of anaesthetics;
• in elderly patients and patients with renal or hepatic impairment, it is possible to increase the plasma concentration of diltiazem, 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 180 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 180 Retard may be associated with mood changes, including depression.

Dilzem 180 Retard and other medicines

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

• lithium - concomitant use with Dilzem 180 Retard may increase the risk of lithium neurotoxicity;
• nitrates - concomitant use with Dilzem 180 Retard may increase the hypotensive effect and the risk of syncope (vasodilatory effect);
• theophylline - concomitant use with Dilzem 180 Retard may increase theophylline plasma concentration;
• alpha-adrenergic receptor blockers - concomitant use of alpha-adrenergic receptor blockers with Dilzem 180 Retard may cause or exacerbate hypotension, so the use of this combination can only be considered under close blood pressure monitoring;
• amiodarone, digoxin - concomitant use with Dilzem 180 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 180 Retard may cause cardiac rhythm disturbances (marked bradycardia, sinoatrial block), conduction disturbances and heart failure;
• other antiarrhythmic medicines - concomitant use with Dilzem 180 Retard may increase the risk of cardiac side effects;
• carbamazepine - concomitant use with Dilzem 180 Retard may increase carbamazepine plasma concentration;
• rifampicin - concomitant use with Dilzem 180 Retard may increase the risk of decreased plasma concentration of diltiazem hydrochloride;
• cimetidine, ranitidine - concomitant use with Dilzem 180 Retard may increase diltiazem plasma concentration;
• cyclosporin - concomitant use with Dilzem 180 Retard may increase cyclosporin plasma concentration, so in the case of combined treatment, it is recommended to reduce the cyclosporin dose, monitor kidney function, control cyclosporin plasma concentration 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 180 Retard is contraindicated during pregnancy, as well as in women of childbearing potential not using effective contraception. In the case of necessity to use Dilzem 180 Retard in breastfeeding women, an alternative method of feeding the child 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 180 Retard contains lactose monohydrate

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

3. How to take Dilzem 180 Retard

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

Taking Dilzem 180 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, half a tablet of Dilzem 180 Retard (equivalent to 2 x 90 mg diltiazem hydrochloride per day). If necessary, the doctor may increase the dose of the medicine 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 the case of long-term treatment with a satisfactory clinical effect, the doctor may check every 2-3 months whether it is possible to reduce the dose of the medicine.
Hypertension
One tablet of Dilzem 180 Retard per day (equivalent to 180 mg diltiazem hydrochloride per day), taken in the morning. If necessary, the doctor may increase the dose of the medicine to a maximum of 360 mg per day (one Dilzem 180 Retard tablet in the morning and one Dilzem 180 Retard tablet in the evening). Do not take doses higher than the maximum daily dose. In the case of a satisfactory antihypertensive effect, the doctor may consider reducing the dose of the medicine.

Taking Dilzem 180 Retard in patients with renal or hepatic impairment

Dilzem 180 Retard should be used with caution in patients with renal or hepatic impairment.

Taking Dilzem 180 Retard in elderly patients

Dilzem 180 Retard should be used with caution in elderly patients.

Taking a higher dose of Dilzem 180 Retard than recommended

Overdose of Dilzem 180 Retard may lead to severe hypotension, including shock, bradycardia (decreased heart rate), heart failure, atrioventricular block or renal dysfunction.
In the event of taking a higher dose of Dilzem 180 Retard than recommended, you should immediately contact your doctor. Depending on the symptoms, the doctor will apply the appropriate treatment.

Missing a dose of Dilzem 180 Retard

If you miss a dose of Dilzem 180 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 180 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 180 Retard

If treatment with Dilzem 180 Retard is to be stopped, the medicine should be discontinued gradually, by reducing the subsequent doses, especially in patients with ischaemic heart disease.
In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is presented according to the MedDRA convention: very common (≥1/10); common (≥1/100 to <1>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 twitching)
Cardiac disorders:
Common: atrioventricular block (first, second or third degree, possible bundle branch block), palpitations
Uncommon: bradycardia (decreased 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, abdominal pain, nausea
Uncommon: vomiting, diarrhoea
Rare: dryness of the oral mucosa
Frequency not known: gingival hyperplasia
Hepatobiliary disorders:
Uncommon: increased liver enzyme activity (ASAT, ALAT, LDH, alkaline phosphatase)
Frequency not known: hepatitis
Skin and subcutaneous tissue disorders:
Common: flushing
Rare: urticaria
Frequency not known: photosensitivity (including lichenoid photodermatosis), angioedema, rash, erythema multiforme (including Stevens-Johnson syndrome and toxic epidermal necrolysis), sweating, exfoliative dermatitis, acute generalized exanthematous pustulosis, rare erythema multiforme with or without fever, a condition in which the immune system attacks the body's own tissues, causing symptoms such as joint swelling, fatigue and rash (called "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 side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reactions to 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dilzem 180 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.
The expiry date (EXP) is 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 that are no longer needed. This 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, hydroxyethyl cellulose, 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 dividing line on both sides. The pack contains 30 tablets.

Marketing authorisation holder

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

Manufacturer

Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
To obtain more detailed information about this medicine, 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:

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