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 this leaflet carefully before you start 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6.Contents of the pack and additional information

Diltiazem Retard Stada belongs to the group of calcium antagonists. Diltiazem Retard Stada is a medication that reduces the heart rate. It has a vasodilating effect. This improves blood circulation from the heart and prevents chest pain due to a lack of oxygen in the heart muscle. Blood circulation in the heart vessels is also improved, and high blood pressure is reduced. This effect lasts 24 hours, and therefore one capsule per day is sufficient.

Diltiazem Retard Stada is used for the treatment of stable angina pectoris.

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

Stable Angina Pectoris

Chest pain is a feeling of pressure in the chest. Pain can radiate to one or both arms, neck, jaw, or back. Chest pain may be associated with angina, oppression, or a sense of alarm. It mainly occurs during effort or agitation. Once calm, symptoms disappear quickly. A "chest pain attack" usually lasts a few minutes, but sometimes it can last longer.

High blood pressure is generally not perceived.The result of high blood pressure treatment can only be evaluated by measurements performed by your doctor.

Do not take Diltiazem Retard Stada:

• If you are allergic to diltiazem or any of the other ingredients of this medication (listed in section 6).
• If you have heart 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 had left ventricular heart failure (left ventricular insufficiency) 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 (heart weakness) etc.).
• If you are receiving dantrolene administered directly into the veins (see section 2 "Taking Diltiazem Retard Stada with other medications").
• If you are already taking a medication that contains ivabradina for the treatment of certain heart diseases.
• If you are already taking a medication that contains lomitapida used for the treatment of high cholesterol levels (see section: "Taking Diltiazem Retard Stada with other medications").

Warnings and precautions

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

• If you need anesthesia (e.g. for surgery), you must 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 must receive close monitoring.
• In patients with advanced age or with reduced kidney or liver function, the plasma concentration of hydrochloride diltiazem may be increased. In this case, it will be necessary to closely monitor the heart rate and electrocardiogram at the beginning of treatment.
• At the beginning of treatment, you must be carefully controlled (especially your heart rate).
• If you experience mood changes during treatment with Diltiazem Retard Stada, including depression, inform your doctor immediately.
• If you experience slow bowel movement or intestinal problems, you must inform your doctor, as Diltiazem Retard Stada may slow down your bowel movement.
• If you have diabetes. In this case, it is necessary to strictly monitor your blood sugar levels.
• If you have a history of heart failure, new difficulty breathing, slow heart rate, 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.

Inform your doctor if any of the above situations occur or have occurred in the past.

Children

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

Taking Diltiazem Retard Stada with other medications

Particularly, do not take this medication and inform your doctor if you are taking:

Medications that contain lomitapida used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of lomitapida, which may lead to an increased risk and severity of liver-related side effects.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• If you receive dantrolene (a muscle relaxant) intravenously
• If you receive ivabradina (a medication indicated for angina pectoris)

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

• Lithium (medication for depression or for extreme mood swings (manic-depressive alteration))
• Nitrate derivatives, alpha blockers, amiodarone, digoxin, beta blockers, antiarrhythmic agents (medications for heart arrhythmias, heart alterations, high blood pressure, and/or chest pain).
• Theophylline (medication for asthma, chronic bronchitis, or emphysema).
• Carbamazepine (medication for epilepsy, mood swings, facial pain, excessive urine production, and symptoms of alcohol withdrawal).
• Ciclosporin (medication that inhibits the immune system after transplants).
• Benzodiazepines (medications for sleep disorders), such as midazolam or triazolam.
• Corticosteroids (medications against inflammation and allergic reactions) such as methylprednisolone.
• Statins (medications for treating high cholesterol levels)
• Phenytoin (a medication for epilepsy)
• Contrast medium for X-ray examinations
• Anesthetics (used during surgery)

Inform your doctor or pharmacist if you are taking any of the following medications. Diltiazem Retard Stada may reduce the effect of these medications:

• Rifampicin (medication for tuberculosis).
• CYP3A4 activators (certain medications that increase liver function) such as St. John's Wort

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

• Antagonists H2 (medications for stomach ulcers), such as cimetidine, famotidine, nizatidine, and ranitidine.

• Inhibitors of CYP3A4 (certain medications that inhibit liver function) such as indinavir, ritonavir, nelfinavir, and nefazodone (antiviral medications for HIV), clarithromycin (antibiotic), itraconazole, ketoconazole, and voriconazole (antifungal medications).

Taking Diltiazem Retard Stada with food and drinks

The juice of grapefruit may increase the effect of Diltiazem Retard Stada

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Small amounts of the active ingredient Diltiazem Retard Stada pass into breast milk. If you are being treated with Diltiazem Retard Stada, you cannot breastfeed. If your doctor prescribes Diltiazem Retard Stada, you must choose another method of feeding your child.

Driving and using machines

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

How much Diltiazem Retard Stada should be taken

The initial dose is one 200 mg capsule per day. In case of insufficient results, your doctor may prescribe one 300 mg capsule per day.

Patients with advanced age 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 have not been established. 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, although always approximately at the same hour, preferably before or during a meal.

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

How long does the 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forgot to take Diltiazem Retard Stada

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

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Diltiazem Retard Stada

Always contact your doctor if you want to interrupt the treatment with Diltiazem Retard Stada before your doctor tells you to, as your previous symptoms may return or worsen.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• skin rash with irregular red patches (erythema multiforme) (including severe allergic reaction with high fever, skin blisters, joint pain, and/or eye inflammation (Stevens-Johnson syndrome) and including sudden severe allergic reaction, with fever and skin blisters and skin peeling (toxic epidermal necrolysis))Not known; the frequency cannot be estimated from the 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; the frequency cannot be estimated from the available data)

The following side effects may occur:

Blood and lymphatic system disorders:

Not known: (cannot be estimated from the available data):

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

Metabolism and nutrition disorders

Not known: (cannot be estimated from the available data):

• high blood sugar levels (hyperglycemia)

Mental health disorders:

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

• anxiety
• difficulty falling asleep (insomnia)

Not known (cannot be estimated from the available data):

• mood changes, including severe low mood (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)

Not known (cannot be estimated from the available data):

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

Cardiac disorders:

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

• certain conduction disorders in the heart, leading to arrhythmias (first-degree, second-degree, or third-degree block or branch block)
• palpitations

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

• slow heart rate (bradycardia)

Not known (cannot be estimated from the available data):

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

Vascular disorders:

Common (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, experiencing dizziness (orthostatic hypotension)

Not known (cannot be estimated from the available data):

• inflammation of blood vessels (vasculitis)

Gastrointestinal disorders:

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

• difficulty digesting 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

Not known (cannot be estimated from the available data):

• inflammation of the gums (gingival hyperplasia)

Hepatobiliary disorders:

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

• increased liver enzymes

Not known (cannot be estimated from the available data):

• inflammation of the liver (hepatitis)

Skin and subcutaneous tissue disorders:

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

• flushing of the skin (erythema)

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

• skin rash with intense itching and blistering (urticaria) and blistering (rash)

Not known (cannot be estimated from the available data):

• photosensitivity or sensitivity to sunlight
• skin rash
• sweating
• inflammation of the skin associated with the appearance of large scales (dermatitis exfoliativa)
• skin rash with pustules on (almost) the entire body (acute generalized pustular psoriasis)
• peeling of the skin 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 and breast disorders:

Not known (cannot be estimated from the available data):

• breast growth 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):

• unwellness
• asthenia/tiredness

Reporting of side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store above 30°C.

Do not use after the expiration date shown on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of packaging and medicines that you no longer need. This will help protect the environment.

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 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), indigotin (E132), and gelatin.

Appearance of the product and contents of the package

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.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer responsible

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 the Member States of the EEA with 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 gelatin capsules

Diltiazem Retard EG 300 mg prolonged-release gelatin capsules

ESDiltiazem Retard STADA 200 mg prolonged-release hard capsules EFG

Diltiazem Retard STADA 300 mg prolonged-release hard capsules EFG

Last review date of this leaflet: June 2023

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es