DILTIAZEM RETARD STADA 300 mg PROLONGED-RELEASE HARD CAPSULES

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

Do not take Diltiazem Retard Stada:

• If you are allergic to diltiazem or any of the other ingredients of this medicine (listed in section 6).
• If you have cardiac arrhythmias (sick sinus syndrome) (except if you have a pacemaker in one of the heart chambers).
• If you have a certain type of heart block (second or third degree atrioventricular block) (except if you have a pacemaker in one of the heart chambers).
• If you have suffered left ventricular heart 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 had a heart attack with complications (e.g. slow heart rate, low blood pressure, congestive heart failure, etc.)
• If you are simultaneously receiving dantrolene administered directly into the veins (see section 2 "Taking Diltiazem Retard Stada with other medicines").
• If you are already taking a medicine that contains ivabradine for the treatment of certain heart diseases.
• If you are already taking a medicine that contains lomitapida used for the treatment of high cholesterol levels (see section: "Taking Diltiazem Retard Stada with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diltiazem Retard Stada:

• If you need anesthesia (e.g. for an operation), you should inform the doctor that you are taking Diltiazem Retard Stada.
• If you have reduced left ventricular heart function, slow pulse, or first-degree heart block, you should receive close monitoring.
• In elderly patients or patients with reduced kidney or liver function, the amount of diltiazem hydrochloride in the blood may be increased. In this case, it will be necessary to closely monitor the heart rate and electrocardiogram at the start of treatment.
• At the start of treatment, you should be carefully monitored (especially your heart rate).
• If you experience mood changes during treatment with Diltiazem Retard Stada, including depression, inform your doctor immediately.
• If you suffer from slow bowel movements or intestinal problems, you should inform your doctor, as Diltiazem Retard Stada may slow down the movement of your intestine.
• If you have diabetes. In this case, strict monitoring of blood sugar levels is necessary.
• If you have a history of heart failure, new difficulty breathing, slow heartbeats, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions, your doctor may need to monitor your kidney function.

Tell your doctor if you have any of the above conditions or if you have had them in the past.

Children

The safety and efficacy of Diltiazem Retard Stada have not been established in children.Diltiazem Retard Stada is not recommended for use 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 that contain lomitapida used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of lomitapida, which may lead to an increased probability and severity of liver-related side effects.

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

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

• If you receive dantrolene (a muscle relaxant) intravenously
• If you receive ivabradine (a medicine for angina pectoris)

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

• lithium (a medicine for depression or extreme mood changes)
• nitrate derivatives, alpha blockers, amiodarone, digoxin, beta blockers, antiarrhythmic agents (medicines for cardiac arrhythmias, cardiac disorders, 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 symptoms of alcohol withdrawal)
• cyclosporin (a medicine that inhibits the immune system after transplants)
• benzodiazepines (medicines for sleep disorders), such as midazolam or triazolam
• corticosteroids (medicines against inflammation and allergic reactions) such as methylprednisolone
• statins (medicines for treating high cholesterol levels)
• phenytoin (a medicine for epilepsy)
• contrast medium for X-ray examinations
• anesthetics (used during operations)

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

• rifampicin (a medicine against tuberculosis)
• CYP3A4 activators (certain medicines that increase liver function) such as St. John's Wort

Tell your doctor or pharmacist if you are taking any 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 have a baby, ask your doctor or pharmacist for advice before taking 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 Retard Stada pass into breast milk. If you are treated with Diltiazem Retard Stada, you should not breastfeed. If your doctor prescribes Diltiazem Retard Stada, you should choose another method of feeding your child.

Driving and using machines

Based on the adverse effects reported as dizziness (frequent) and malaise (frequent), the ability to drive and use machines may be affected. However, no studies have been conducted.

3. How to take Diltiazem Retard Stada

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

How much Diltiazem Retard Stada to take

The initial dose is one 200 mg capsule per day. If the 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 have not been established in children. The use of Diltiazem Retard Stada is not recommended in children.

How to take Diltiazem Retard Stada

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

The capsule should not be crushed or chewed, it should be swallowed whole with a little liquid.

How long to take Diltiazem Retard Stada

Diltiazem Retard Stada is usually 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, phone: 91 562 04 20, indicating the medicine and the amount ingested.

Taken in large quantities, inform your doctor or go immediately to the emergency department of a hospital. Bring the medicine pack with you. This is so that the doctor knows what you have taken. The following effects may occur: feeling of dizziness or weakness, blurred vision, chest pain, difficulty breathing, fainting, unusually fast or slow heartbeats, difficulty speaking, confusion, decreased kidney function, coma, and sudden death.

If you forget to take Diltiazem Retard Stada

You may forget to take a dose. In that case, it is not necessary to take the missed dose. You can take the prescribed dose the next day.

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

If you stop taking Diltiazem Retard Stada

Always contact your doctor if you want to stop taking Diltiazem Retard Stada before he has told you to, as the symptoms you had before treatment may return or worsen.

If you have any further questions on 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 all people suffer from 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 includes sudden severe allergic reaction, with fever and blisters on the skin and skin peeling (toxic epidermal necrolysis)) (Unknown; frequency cannot be estimated from available data)
• sudden accumulation of fluid in the skin and mucous membranes (e.g., throat or tongue), breathing difficulties and/or itching and rash, often as an allergic reaction (angioedema) (Unknown; frequency cannot be estimated from available data)

The following adverse effects may appear:

Blood and Lymphatic System Disorders:

Unknown frequency: (cannot be estimated from available data):

• blood disorders with symptoms such as bruising and bleeding tendency (thrombocytopenia).

Metabolic and Nutritional Disorders

Unknown frequency: (cannot be estimated from available data):

• increased blood sugar levels (hyperglycemia)

Psychiatric Disorders:

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

• nervousness
• difficulty falling asleep (insomnia)

Unknown frequency (cannot be estimated from available data):

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

Nervous System Disorders

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

• dizziness
• headache

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

• loss of consciousness (syncope)

Unknown frequency (cannot be estimated from available data):

• tremor, stiffness, reduced mobility
• increased saliva production and restlessness (extrapyramidal symptoms).

Cardiac Disorders:

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

• certain cardiac conduction disorders, leading to arrhythmias (1st, 2nd, or 3rd degree cardiac block or branch block).
• heart palpitations

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

• slow heart rate (bradycardia).

Unknown frequency (cannot be estimated from available data):

• certain cardiac conduction disorders, leading to arrhythmias (sinoatrial block)
• insufficient cardiac contraction, leading to increased pressure in the heart's blood vessels (congestive heart failure).
• specific cardiac arrhythmia with a pause of more than 2 seconds between 2 heartbeats (sinus arrest)
• cardiac arrest/asystole (heart failure)

Vascular Disorders:

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

• flushing (sudden redness of the 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, experiencing dizziness (orthostatic hypotension).

Unknown frequency (cannot be estimated from available data):

• inflammation of blood vessels (vasculitis).

Gastrointestinal Disorders:

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

• difficult digestion with a feeling of being full 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.

Unknown frequency (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.

Unknown frequency (cannot be estimated from available data):

• inflammation of the liver (hepatitis).

Skin and Subcutaneous Tissue Disorders:

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

• skin redness (erythema).

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

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

Unknown frequency (cannot be estimated from available data):

• hypersensitivity to light or sun (photosensitivity).
• skin rash.
• sweating
• inflammation of the skin associated with the appearance of large scales (exfoliative dermatitis).
• sudden skin rash with pustules on (almost) the entire body (acute generalized exanthematous pustulosis).
• skin peeling with rash with or without fever.
• condition in which the body's defense system attacks normal tissue, causing symptoms such as inflamed joints, fatigue, and skin rashes (called "lupus-like syndrome").

Reproductive System and Breast Disorders:

Unknown frequency (cannot be estimated from available data):

• breast growth in men (gynecomastia).

General Disorders and Administration Site Conditions:

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

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

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

• discomfort
• asthenia/fatigue

Reporting of Adverse Effects

If you experience any of the adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Diltiazem Retard Stada

The active ingredient of 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 ingredients 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 ingredients 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 and Package Contents

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, 100 prolonged-release hard capsules.

Not all 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 medicine is authorized in the EEA member states under the following names:

NLDiltiazem HCl retard CF 200 mg, hard capsules with prolonged release

Diltiazem HCl retard CF 300 mg, hard capsules with prolonged release

BEDiltiazem Retard EG 200 mg hard capsules with prolonged release

Diltiazem Retard EG 300 mg hard capsules with prolonged release

LUDiltiazem Retard EG 200 mg prolonged-release capsules

Diltiazem Retard EG 300 mg prolonged-release capsules

ESDiltiazem Retard STADA 200 mg hard capsules with prolonged release EFG

Diltiazem Retard STADA 300 mg hard capsules with prolonged release EFG

Date of the last revision of this leaflet: June 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es