DILTIAZEM DERMOGEN 200 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Diltiazem Dermogen 200 mg prolonged-release hard capsules EFGDiltiazem hydrochloride

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Diltiazem Dermogen 200 mg and what is it used for
2. What you need to know before taking Diltiazem Dermogen 200 mg
3. How to take Diltiazem Dermogen 200 mg
4. Possible side effects
5. Storage of Diltiazem Dermogen 200 mg
6. Package contents and additional information

1. What is Diltiazem Dermogen 200 mg and what is it used for

Diltiazem Dermogen 200 mg belongs to a group of medicines called selective calcium channel blockers with direct cardiac effects, derived from benzothiazepine.

Diltiazem Dermogen 200 mg is indicated for the preventive treatment of stable angina attacks. The prolonged-release formulation of Diltiazem Dermogen 200 mg makes it possible for diltiazem to be absorbed in a prolonged manner, allowing for single daily administration.

2. What you need to know before taking Diltiazem Dermogen 200 mg

Do not take Diltiazem Dermogen 200 mg

• If you are allergic to diltiazem hydrochloride or any of the other components of this medicine (listed in section 6).
• If you have any rhythm or conduction disorders, such as sinus node dysfunction syndrome in patients without a pacemaker, second- or third-degree atrioventricular block in patients without a pacemaker, or severe bradycardia (heart rate less than 40 beats per minute).
• If you have any heart disease, such as left ventricular insufficiency with pulmonary congestion.
• If you are being treated with dantrolene.
• If you are taking medications containing ivabradine for the treatment of certain heart diseases.
• If you are already taking a medication containing lomitapida used for the treatment of high cholesterol levels (see section: "Taking Diltiazem Dermogen 200 mg with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diltiazem Dermogen 200 mg.

• If you have heart conditions such as bradycardia (slow heart rate) or first-degree atrioventricular block (a type of arrhythmia) detected electrocardiographically, your doctor will need to closely monitor you.
• If you are an elderly patient or have kidney or liver disease, diltiazem blood levels may be higher, so your doctor will need to closely monitor your heart rate at the start of treatment.
• In the event of general anesthesia, you should inform the anesthesiologist that you are being treated with this medicine.
• Since this type of medicine (calcium channel blockers) may be associated with mood changes, including depression.
• If you are at risk of developing intestinal obstruction, as diltiazem, like other medicines in the same group, reduces intestinal movement.
• If you have latent or manifest diabetes mellitus. Strict control is necessary in these patients due to the possible increase in blood glucose levels.
• 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, so your doctor may need to monitor your kidney function.

Children

Diltiazem Dermogen 200 mg is not a suitable medicine for children.

Taking Diltiazem Dermogen 200 mg with other medicines

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

Note that these instructions may also apply to medicines taken before or after.

Certain medicines may interact with Diltiazem Dermogen 200 mg. In these cases, it may be convenient to change the dose or interrupt treatment with one of the medicines.

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

• Medicines containing lomitapida used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of lomitapida, which can lead to an increased probability and severity of liver-related side effects.

It is especially important that you inform your doctor if you are taking any of the following medicines:

Medicines for heart problems, such as:

• Alpha blockers
• Beta blockers
• Amiodarone, digoxin
• Antiarrhythmic medicines
• Nitrate derivatives

As the effects of both may be additive, potentially leading to the appearance of side effects, so caution should be exercised when combining them with diltiazem.

• Cyclosporin (immunosuppressive medicine used in transplants).
• Carbamazepine (for treating epilepsy).
• Theophylline (medicine for asthma).

Since diltiazem increases the amount of these medicines circulating in the blood, your doctor will need to adjust the dose of these medicines during treatment with diltiazem.

• H2 antagonists (cimetidine and ranitidine), medicines for treating stomach ulcers, as they increase the amount of diltiazem in the blood, so either treatment with these will be interrupted, or the daily dose of diltiazem will be adjusted.
• Rifampicin (antibiotic used for treating tuberculosis and some infections), which may decrease the amount of diltiazem in the blood, so your doctor will closely monitor you.
• Lithium (medicine for treating mental health problems), as it may increase the toxicity of lithium. Your doctor will closely monitor your lithium blood levels.
• Medicines metabolized by the CYP3A4 enzyme, as this may result in a decrease in the amount of diltiazem in the blood or an increase in the amount of any of the medicines administered with it.
• Benzodiazepines (midazolam, triazolam), which are sedative, anxiolytic, anticonvulsant, amnestic, and muscle relaxant medicines. Since diltiazem increases the amounts of these medicines in the blood, prolonging their stay in the body. Your doctor will be especially careful when prescribing benzodiazepines (especially short-acting ones) if you are taking diltiazem.
• Corticosteroids (methylprednisolone) used as anti-inflammatory and in severe allergies due to their immunosuppressive capacity. Since diltiazem reduces the metabolism of this, your doctor will closely monitor you and adjust the dose of methylprednisolone.
• Statins (medicines used to lower cholesterol), as diltiazem greatly increases the amount of some statins in the blood, which could lead to statin toxicity problems. The simultaneous use of diltiazem with dantrolene is contraindicated.

Taking Diltiazem Dermogen 200 mg with food and drinks

The pharmacological effect of Diltiazem Dermogen 200 mg is not altered by the ingestion of food or drinks. Its administration can be done before or during main meals, at any time of the day, but it is recommended to always take it at the same time.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. This medicine should not be administered to pregnant women or women of childbearing age who are not using an effective contraceptive method. This medicine should not be taken during breastfeeding, as it passes into breast milk. If the doctor considers it essential to take this medicine, the baby should be fed by an alternative method.

Driving and using machines

Based on the side effects reported with the use of Diltiazem Dermogen, such as dizziness (frequent) and discomfort (frequent), the ability to drive and use machines may be altered, although no studies have been conducted on this.

3. How to take Diltiazem Dermogen 200 mg

Follow the administration instructions of this medicine indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again. Your doctor will indicate the duration of your treatment with Diltiazem Dermogen 200 mg. Do not stop treatment before.

Remember to take your medicine.

The route of administration of Diltiazem Dermogen 200 mg is oral. The capsule should be swallowed whole, without being opened or chewed.

The dose you need will be determined by your doctor and adjusted individually for you.

The recommended dose is:

• Adults: The daily dose will be one capsule of Diltiazem Dermogen 200 mg per day, i.e., 200 mg of diltiazem hydrochloride per day.
• Elderly patients: See "Be careful with Diltiazem Dermogen 200 mg".

It is not recommended to substitute diltiazem specialties with each other unless you receive the express recommendation of your doctor.

If you take more Diltiazem Dermogen 200 mg than you should

If you take more tablets than you should, inform your doctor or go immediately to the emergency department of a hospital. Bring the medicine package 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.

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. If you have taken more Diltiazem Dermogen 200 mg than you should, consult your doctor or pharmacist immediately.

A too high dose of Diltiazem Dermogen 200 mg can cause a decrease in blood pressure, slowing of the heart rate, and alterations in cardiac conduction.

In case of significant overdose, the patient should be transferred to a specialized center and gastric lavage and osmotic diuresis should be performed.

Atropine, adrenaline, glucagon, or calcium gluconate may be administered as antidotes.

If you forget to take Diltiazem Dermogen 200 mg

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, take it as soon as you can and take the next one at the usual time. However, if it is already time for the next dose or close to it, wait and take it at this time.

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

4. Possible side effects

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

The following side effects have been reported according to the frequencies detailed below:

Very common:may affect more than 1 in 10 patients

Common:may affect up to 1 in 10 patients

Uncommon:may affect up to 1 in 100 patients

Rare:may affect up to 1 in 1,000 patients

Very rare:may affect up to 1 in 10,000 patients

Frequency not known(cannot be estimated from available data)

Blood and lymphatic system disorders:

Frequency not known:thrombocytopenia

Metabolism and nutrition disorders:

Frequency not known:hyperglycemia.

Nervous system disorders:

Common:headache, dizziness.

Frequency not known:movement disorders (extrapyramidal syndrome).

Psychiatric disorders:

Uncommon:nervousness, difficulty falling asleep (insomnia).

Frequency not known:mood changes, including depression.

Cardiac disorders:

Common:atrioventricular block (a type of arrhythmia), palpitations.

Uncommon:slow heart rate (bradycardia).

Frequency not known:sinoatrial block, difficulty of the heart to pump blood (congestive heart failure).

General disorders and administration site conditions:

Very common:edema in the lower limbs.

Common:discomfort.

Gastrointestinal disorders:

Common:constipation, difficult digestion (dyspepsia), stomach pain, nausea.

Uncommon:vomiting, diarrhea.

Rare:dry mouth.

Frequency not known:inflammation of the hard palate (gingival hyperplasia).

Skin and subcutaneous tissue disorders:

Common:skin redness (erythema).

Rare:skin irritation and itching (urticaria).

Frequency not known:sensitivity to light (photosensitivity), inflammation of the throat, lips, and respiratory tract (angioneurotic edema), erythema multiforme (a serious skin disease associated with red spots, blisters), including rare cases of Stevens-Johnson syndrome (severe vesicular reactions of the skin and mucous membranes), toxic epidermal necrolysis (a scaling disease of the skin), sweating, exfoliative dermatitis (redness of the skin, itching, hair loss), and generalized acute pustular exanthema (sudden eruption accompanied by fever, with the formation of pustules or lesions on the skin surface characterized by being small, inflamed, filled with pus, and similar to a blister). A 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").

Vascular disorders:

Common:redness.

Uncommon:drop in blood pressure when standing up quickly, with or without dizziness (orthostatic hypotension).

Frequency not known:vasculitis (diseases that cause inflammation of blood vessels), including leucocytoclastic vasculitis.

Hepatobiliary disorders:

Uncommon:increase in liver enzyme levels in the blood during the initial treatment period. These elevations are generally transient. Clinical hepatitis (liver disease) that disappears when treatment with diltiazem is interrupted.

Frequency not known:hepatitis (inflammatory disease that affects the liver).

Reproductive system and breast disorders:

Frequency not known:excessive breast volume in men (gynecomastia).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaRAM.es). By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Diltiazem Dermogen 200 mg

Do not store above 30°C.

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

Do not use this medicine after the expiration date that appears on the package, after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of packages and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Diltiazem Dermogen 200 mg prolonged-release capsules EFG

• The active ingredient is diltiazem hydrochloride. Each prolonged-release capsule contains 200 mg of diltiazem hydrochloride.
• The other components are: povidone, ethylcellulose, talc, stearic acid. The capsule is composed of: gelatin, titanium dioxide (E-171)

Appearance of the product and package contents

The Diltiazem Dermogen 200 mg capsules are opaque, with a white body and cap, filled with white or off-white pellets.

It is presented in packages of 28 prolonged-release capsules.

Marketing authorization holder and manufacturerMarketing authorization holder

DERMOGEN FARMA, S.A.

C/ Aragoneses, 15

28108, Alcobendas (Madrid)

Manufacturer

TOLL MANUFACTURING SERVICES, S.L.

C/ Aragoneses, 2

28108, Alcobendas (Madrid)

Or

FARMEA

10, rue Bouché Thomas.

49000 ZAC d’Orgemont - Angers

France

Or

LAMP SAN PROSPERO S.p.A

Via della Pace 25/A.

41030, San Prospero-Modena

Italy

This leaflet was approved in: May 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/