Dilzem retard

Patient Information Leaflet

Dilzem Retard, 90 mg, prolonged-release tablets
Diltiazemi hydrochloridum
Please read this leaflet carefully before taking this medicine, as 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 share it with others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Dilzem Retard is and what it is used for
2. What you need to know 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 Dilzem Retard is and what it is used for

Dilzem Retard belongs to a group of medicines called calcium channel blockers. These medicines act on smooth muscle of blood vessels and also have a significant effect on the heart muscle. Dilzem 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 Retard

When not to use Dilzem 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 those with an implanted functioning ventricular pacemaker;
• in patients with second- or third-degree atrioventricular block, except those with an implanted functioning 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 Retard with other medicines").

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

• caution should be exercised in patients with impaired left ventricular function, bradycardia, or first-degree atrioventricular block;
• if general anaesthesia is required, inform the doctor about taking Dilzem Retard, as it may enhance disturbances in myocardial contractility, conduction, and automaticity, as well as potentiate 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 should be exercised in patients at risk of intestinal obstruction, as Dilzem Retard may reduce 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, slow heartbeat, or low blood pressure. Since cases of kidney damage have been reported in patients with such conditions, the doctor may recommend monitoring kidney function.

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

Dilzem Retard with other medicines
Dilzem Retard may enhance the effects of other medicines taken concurrently.
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use.

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

Taking Dilzem Retard with food and drink
Tablets should be taken whole, before meals, with sufficient fluid (e.g. one glass of water).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The use of Dilzem Retard is contraindicated during pregnancy and in women of childbearing potential who are not using effective contraceptive methods. If Dilzem Retard must be used during breastfeeding, an alternative method of infant feeding should be employed.

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

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

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

3. How to use Dilzem Retard

This medicine should be used according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The dosing regimen below is recommended for adults.

Coronary heart disease
Twice daily, 1 tablet of Dilzem Retard (corresponding to 180 mg of diltiazem hydrochloride per day).
If necessary, the dose may be increased up to 360 mg per day. During long-term treatment with satisfactory clinical effect, it is recommended to check every 2–3 months whether dose reduction is possible.

Arterial hypertension
Twice daily, 1 prolonged-release tablet of Dilzem Retard (corresponding to 180 mg of diltiazem hydrochloride per day).
If necessary, the dose may be increased to a maximum of 360 mg per day. When a satisfactory antihypertensive effect has been achieved, your doctor may consider reducing the dose.

Use of Dilzem Retard in patients with renal or hepatic impairment
Dilzem Retard should be used with caution in patients with impaired renal or liver function.

Use of Dilzem Retard in children and adolescents
Safety data for use in this patient group have not been evaluated.

Use of Dilzem Retard in elderly patients
Dilzem Retard should be used with caution in elderly patients.

Use of a higher than recommended dose of Dilzem Retard
Overdose of Dilzem Retard may lead to severe hypotension, including shock, bradycardia (reduced heart rate), heart failure, atrioventricular block, or renal dysfunction.
If you take more Dilzem Retard than recommended, contact your doctor immediately. Depending on the symptoms present, the doctor will initiate appropriate treatment.

Missed dose of Dilzem Retard
If a patient forgets to take Dilzem Retard, they should take it as soon as possible, unless it is almost time for the next dose. In that case, the next dose should be taken at the scheduled time. Do not take a double dose to make up for a missed dose.

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

Discontinuation of Dilzem Retard
If treatment with Dilzem Retard needs to be stopped, the medicine should be withdrawn gradually by reducing the dose step by step, especially in patients with coronary heart disease.

If you have any further doubts regarding 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 will experience them.
You should stop taking Dilzem Retard and contact your doctor immediately if
any of the following symptoms occur:

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

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

• Swelling of the legs

Common (may occur in not more than 1 in 10 people)

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

Uncommon (may occur in not more than 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 occur in not more than 1 in 1,000 people)

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

Frequency not known (cannot be estimated from available data)

• Decreased number of blood platelets (thrombocytopenia)
• Decreased appetite, increased blood sugar levels (hyperglycaemia)
• Mood changes, including depression, disorientation, hallucinations, personality changes and sleep pattern changes
• Movement disorders (extrapyramidal syndrome), memory loss (amnesia), tingling or burning sensations (paresthesia), 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 disturbance of electrical signals in the heart (sinoatrial block, sinus arrest), difficulty in pumping blood by the heart (congestive heart failure), rapid heartbeat (tachycardia), irregular heartbeats (extrasystoles), irregular heartbeat (arrhythmia), chest pain or pressure (angina pectoris)
• Inflammation of blood vessels (vasculitis)
• Breathing difficulties (dyspnoea), nosebleeds, nasal mucosa congestion
• Gum inflammation (gingival hyperplasia)
• Liver inflammation (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), acute generalized exanthematous pustulosis (sudden rash with fever, accompanied by pustules or skin lesions that are small, inflamed, pus-filled and blister-like), small red spots on the skin (petechiae), itching (pruritus)
• Joint pain, muscle pain
• Need to urinate at night (nocturia), increased frequency of urination (polyuria)
• Enlargement of breasts 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 tissues, causing symptoms such as joint inflammation, fatigue 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 authorization holder or its representative.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dilzem Retard

Keep this medicine out of 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) refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dilzem Retard contains

• The active substance is diltiazem hydrochloride. Each tablet contains 90 mg of diltiazem hydrochloride.
• Other ingredients are: monohydrate lactose (see section 2 "Dilzem Retard contains monohydrate lactose"), hydrogenated castor oil, stearic acid, sodium carboxymethylcellulose (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 Bruxelles
Belgium
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany
For further information, 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 is available by scanning the QR code
located 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 .