Diltiazem Retard Stada 300 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diltiazem Retard Stada 200 mg prolonged-release hard capsules EFG

Diltiazem Retard Stada 300 mg prolonged-release hard capsules EFG

diltiazem hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any 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 get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Diltiazem Retard Stada is and what it is used for

2. What you need to know before taking Diltiazem Retard Stada

3. How to take Diltiazem Retard Stada

4. Possible side effects

5. How to store Diltiazem Retard Stada

6. Contents of the pack and other information

1. What Diltiazem Retard Stada is and what it is used for

Diltiazem Retard Stada belongs to the group of calcium antagonists. Diltiazem Retard Stada is a medicine that reduces heart rate. It has a vasodilatory effect. This improves blood flow from the heart and prevents chest pain caused by lack of oxygen in the heart muscle. It also improves circulation in the heart's blood vessels and reduces high blood pressure. This effect lasts for 24 hours, so one capsule per day is sufficient.

Diltiazem Retard Stada is used for the treatment of chest pain (stable angina).

Diltiazem Retard Stada is used for the treatment of mild to moderate high blood pressure.

Chest pain (stable angina)

Chest pain is a feeling of pressure in the chest. The pain may radiate to one or both arms, neck, jaw, or back. Chest pain may be associated with angina, tightness, or a sense of alarm. It mainly occurs during physical exertion or emotional stress. Once the activity stops, symptoms quickly subside. An episode of chest pain usually lasts a few minutes, but sometimes may last longer.

High blood pressure is generally not noticeable. The effectiveness of treatment for high blood pressure can only be assessed through measurements taken by your doctor.

2. What you need to know before taking Diltiazem Retard Stada

Do not take Diltiazem Retard Stada:

• If you are allergic to diltiazem or to any of the other ingredients of this medicine (listed in section 6).
• If you have heart rhythm disorders (sick sinus syndrome) (unless you have a pacemaker implanted in one of the heart chambers).
• If you have certain types of heart block (second- or third-degree atrioventricular block) (unless you have a pacemaker implanted in one of the heart chambers).
• If you have previously experienced left-sided heart chamber failure (left ventricular failure) with pulmonary congestion.
• If you have a slow heart rate (bradycardia, less than 40 beats per minute).
• If you have low blood pressure (hypotension) for any reason.
• If you have recently had a heart attack with complications (e.g. slow heart rate, low blood pressure, congestive heart failure (heart weakness), etc.).
• If you are simultaneously receiving intravenous dantrolene (see section 2 “Taking Diltiazem Retard Stada with other medicines”).
• If you are already taking a medicine containing ivabradine for the treatment of certain heart conditions.
• If you are already taking a medicine containing lomitapide used for the treatment of high cholesterol levels (see section: “Taking Diltiazem Retard Stada with other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist before starting Diltiazem Retard Stada:

• If you require anesthesia (e.g. for surgery), you must inform your doctor that you are taking Diltiazem Retard Stada.
• If you have reduced function of the left heart chamber, slow pulse, or first-degree heart block, careful monitoring is required.
• In elderly patients or in patients with reduced kidney or liver function, plasma levels of diltiazem hydrochloride may be increased. In such cases, close monitoring of heart rate and electrocardiogram (ECG) is necessary at the beginning of treatment.
• You should be carefully monitored at the start of treatment (especially your heart rate).
• If you experience mood changes during treatment with Diltiazem Retard Stada, including depression, inform your doctor immediately.
• If you have slow intestinal movement or gastrointestinal problems, inform your doctor, as Diltiazem Retard Stada may slow down intestinal motility.
• If you have diabetes. In this case, strict monitoring of blood sugar levels is necessary.
• If you have a history of heart failure, new onset of breathing difficulty, slow heartbeats, or low blood pressure. Cases of kidney injury have been reported in patients with these conditions; your doctor may need to monitor your kidney function.

Inform your doctor if you experience any of the conditions listed above or have experienced them in the past.

Children

The safety and efficacy of Diltiazem Retard Stada have not been established in children. Use of Diltiazem Retard Stada is not recommended in children.

Taking Diltiazem Retard Stada with other medicines

In particular, do not take this medicine and inform your doctor if you are taking:

Medicines containing lomitapide used for the treatment of high cholesterol levels. Diltiazem may increase lomitapide concentrations, which could lead to an increased frequency and severity of liver-related side effects.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Diltiazem Retard Stada and inform your doctor or pharmacist immediately:

• If you are receiving dantrolene (a muscle relaxant) intravenously.
• If you are receiving ivabradine (a medicine indicated for angina pectoris).

Tell your doctor or pharmacist if you are taking any of the following medicines. Diltiazem Retard Stada may increase the effects of these medicines:

• Lithium (a medicine for depression or extreme mood changes (manic-depressive disorder)).
• Nitrate derivatives, alpha-blockers, amiodarone, digoxin, beta-blockers, antiarrhythmic agents (medicines for heart rhythm disorders, heart conditions, high blood pressure, and/or chest pain).
• Theophylline (a medicine for asthma, chronic bronchitis, or emphysema).
• Carbamazepine (a medicine for epilepsy, mood changes, facial pain, excessive urine production, and alcohol withdrawal symptoms).
• Cyclosporine (a medicine that suppresses the immune system after transplants).
• Benzodiazepines (medicines for sleep disorders), such as midazolam or triazolam.
• Corticosteroids (medicines for inflammation and allergic reactions), such as methylprednisolone.
• Statins (medicines for treating high cholesterol levels).
• Phenytoin (a medicine for epilepsy).
• Contrast agents for X-ray imaging.
• Anesthetics (used during surgery).

Tell your doctor or pharmacist if you are taking one of the following medicines. They may reduce the effect of Diltiazem Retard Stada:

• Rifampicin (a medicine for tuberculosis).
• CYP3A4 inducers (certain medicines that increase liver function), such as St. John’s wort.

Tell your doctor or pharmacist if you are taking one of the following medicines. They may increase the effect of Diltiazem Retard Stada:

• H2 antagonists (medicines for stomach ulcers), such as cimetidine, famotidine, nizatidine, and ranitidine.
• Strong CYP3A4 inhibitors (certain medicines that inhibit liver function), such as indinavir, ritonavir, nelfinavir, and nefazodone (antiviral medicines for HIV infections), clarithromycin (an antibiotic), itraconazole, ketoconazole, and voriconazole (antifungal medicines).

Taking Diltiazem Retard Stada with food and drinks

Grapefruit juice may increase the effect of Diltiazem Retard Stada.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of Diltiazem Retard Stada is not recommended during pregnancy or in women of childbearing potential who are not using effective contraceptive methods.

Small amounts of the active substance Diltiazem pass into breast milk. If you are being treated with Diltiazem Retard Stada, you must not breastfeed. If your doctor prescribes Diltiazem Retard Stada, you must choose an alternative method of feeding for your child.

Driving and using machines

Based on reported adverse effects such as dizziness (common) and malaise (common), the ability to drive and operate machinery may be affected. However, no specific studies have been conducted.

3. How to take Diltiazem Retard Stada

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How much Diltiazem Retard Stada to take

The initial dose is one 200 mg capsule per day. If results are insufficient, your doctor may prescribe one 300 mg capsule per day.

Elderly patients and patients with reduced liver or kidney function

The dose is one 200 mg capsule per day.

Use in children

The safety and efficacy of Diltiazem Retard Stada in children has not been established. The use of Diltiazem Retard Stada is not recommended in children.

How to take Diltiazem Retard Stada

The capsules may be taken at any time of day, but always approximately at the same time, preferably before or during a meal.

The capsule must not be crushed or chewed; it should be swallowed whole with some liquid.

How long does treatment with Diltiazem Retard Stada last?

Diltiazem Retard Stada is generally prescribed for long periods of time. Follow your doctor's instructions.

If you take more Diltiazem Retard Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If taken in large quantities, inform your doctor or go immediately to the emergency department of a hospital. Take the medicine packaging with you. This is so the doctor knows what you have taken. The following effects may occur: dizziness or weakness, blurred vision, chest pain, difficulty breathing, fainting, abnormally fast or slow heartbeat, difficulty speaking, confusion, reduced kidney function, coma, and sudden death.

If you forget to take Diltiazem Retard Stada

You may forget to take a dose. In this case, do not take the missed dose. Take the prescribed dose the following day.

Do not take a double dose to make up for a missed dose.

If you stop taking Diltiazem Retard Stada

Always contact your doctor if you wish to stop treatment with Diltiazem Retard Stada before they have instructed you to do so, as symptoms present before treatment may return or worsen.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience any of the following adverse reactions:

• Skin rash with irregular red spots (erythema multiforme) (including severe allergic reaction with high fever, blisters on the skin, joint pain and/or eye inflammation (Stevens-Johnson syndrome), and including sudden severe allergic reaction with fever, skin blisters and skin peeling (toxic epidermal necrolysis)) (Not known; frequency cannot be estimated from available data)
• Sudden accumulation of fluid in the skin and mucous membranes (e.g., throat or tongue), difficulty breathing and/or itching and rash, often as an allergic reaction (angioedema) (Not known; frequency cannot be estimated from available data)

The following adverse effects may occur:

Blood and lymphatic system disorders:

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

• Blood disorders with symptoms such as bruising and tendency to bleed (thrombocytopenia).

Metabolism and nutrition disorders:

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

• Increased blood sugar levels (hyperglycemia)

Psychiatric disorders:

Uncommon (may affect up to 1 in 100 people):

• Restlessness
• Difficulty sleeping (insomnia)

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

• Mood changes, including low mood (severe) (depression)

Nervous system disorders:

Common (may affect up to 1 in 10 people):

• Dizziness
• Headache

Uncommon (may affect up to 1 in 100 people):

• Loss of consciousness (syncope)

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

• Tremor, rigidity, reduced mobility
• Increased salivation and restlessness (extrapyramidal symptoms)

Cardiac disorders:

Common (may affect up to 1 in 10 people):

• Certain disorders in cardiac conduction, leading to arrhythmias (1st, 2nd or 3rd degree heart block or bundle branch block)
• Palpitations

Uncommon (may affect up to 1 in 100 people):

• Slow heart rate (bradycardia)

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

• Certain disorders in cardiac conduction, leading to arrhythmias (sinoatrial heart block)
• Inadequate force of heart contraction, causing increased pressure in the blood vessels of the heart (congestive heart failure)
• Specific cardiac arrhythmia with a pause of more than 2 seconds between two beats (sinus arrest)
• Cardiac arrest/asystole (heart failure)

Vascular disorders:

Common (may affect up to 1 in 10 people):

• Flushing (sudden redness of face and neck)

Uncommon (may affect up to 1 in 100 people):

• Drop in blood pressure when standing up quickly from a lying or sitting position, causing dizziness (orthostatic hypotension)

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

• Inflammation of blood vessels (vasculitis)

Gastrointestinal disorders:

Common (may affect up to 1 in 10 people):

• Indigestion with feeling of fullness or stomach pain, belching, nausea, vomiting, and heartburn (dyspepsia)
• Stomach pain
• Nausea
• Constipation

Uncommon (may affect up to 1 in 100 people):

• Vomiting
• Diarrhea

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

• Dry mouth

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

• Inflammation of the gums (gingival hyperplasia)

Hepatobiliary disorders:

Uncommon (may affect up to 1 in 100 people):

• Increase in liver enzymes

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

• Inflammation of the liver (hepatitis)

Skin and subcutaneous tissue disorders:

Common (may affect up to 1 in 10 people):

• Redness of the skin (erythema)

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

• Skin rash with intense itching (urticaria) and blister formation (hives)

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

• Hypersensitivity to light or sunlight (photosensitivity)
• Skin rash
• Sweating
• Skin inflammation associated with large scales (exfoliative dermatitis)
• Sudden rash with pustules over (almost) the entire body (generalized pustular eruption)
• Skin peeling with rash with or without fever
• Condition in which the body's immune system attacks normal tissue, causing symptoms such as swollen joints, fatigue, and skin rashes (called "lupus-like syndrome")

Reproductive system and breast disorders:

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

• Breast enlargement in men (gynecomastia)

General disorders and administration site conditions:

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

• Fluid accumulation in the ankles, legs or arms, for example (peripheral edema)

Common (may affect up to 1 in 10 people):

• Malaise
• Asthenia/fatigue

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diltiazem Retard Stada

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point located at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diltiazem Retard Stada

The active substance in Diltiazem Retard Stada is diltiazem hydrochloride.

200 mg: Each prolonged-release hard capsule contains 200 mg of diltiazem hydrochloride.

300 mg: Each prolonged-release hard capsule contains 300 mg of diltiazem hydrochloride.

The other components of Diltiazem Retard Stada 200 mg prolonged-release hard capsules are povidone K30, ethylcellulose (E462), talc, stearic acid, titanium dioxide (E171) and gelatin.

The other components of Diltiazem Retard Stada 300 mg prolonged-release hard capsules are povidone K30, ethylcellulose (E462), talc, stearic acid, titanium dioxide (E171), quinoline yellow (E104), indigotine (E132) and gelatin.

Appearance of the product and contents of the pack

Diltiazem Retard Stada 200 mg prolonged-release hard capsules are white capsules.

Diltiazem Retard Stada 300 mg prolonged-release hard capsules are green/white capsules.

Diltiazem Retard Stada (200 mg and 300 mg) prolonged-release hard capsules are available in blister packs containing 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98 or 100 prolonged-release hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Sanico NV

Veedijk 59

2300 Turnhout

Belgium

or

Lamp San Prospero

Via Della Pace 25/A

41030 San Prospero S/S (Modena)

Italy

or

Eurogenerics NV

Heizel Esplanade b22

1020 Brussels

Belgium

This medicinal product is authorized in EEA Member States under the following names:

NL Diltiazem HCl retard CF 200 mg, harde capsules met verlengde afgifte

Diltiazem HCl retard CF 300 mg, harde capsules met verlengde afgifte

BE Diltiazem Retard EG 200 mg harde capsules met verlengde afgifte

Diltiazem Retard EG 300 mg harde capsules met verlengde afgifte

LU Diltiazem Retard EG 200 mg gélules à libération prolongée

Diltiazem Retard EG 300 mg gélules à libération prolongée

ES Diltiazem Retard STADA 200 mg cápsulas duras de liberación prolongada EFG

Diltiazem Retard STADA 300 mg cápsulas duras de liberación prolongada EFG

Date of the most recent revision of this leaflet: June 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es