DILTIAZEM FARMALIDER 300 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Diltiazem Farmalider 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 further 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Diltiazem Farmalider 300 mg is and what it is used for
2. What you need to know before you take Diltiazem Farmalider 300 mg
3. How to take Diltiazem Farmalider 300 mg
4. Possible side effects
5. Storage of Diltiazem Farmalider 300 mg
6. Contents of the pack and other information

1. What Diltiazem Farmalider 300 mg is and what it is used for

Diltiazem Farmalider 300 mg belongs to a group of medicines called selective calcium channel blockers with direct cardiac effects, derived from benzothiazepine.

Diltiazem Farmalider 300 mg is indicated for the treatment of angina pectoris and mild to moderate arterial hypertension (elevation of blood pressure). The prolonged-release formulation of Diltiazem Farmalider 300 mg makes it possible for the absorption of diltiazem to take place in a prolonged manner, allowing for single daily administration.

2. What you need to know before you take Diltiazem Farmalider 300 mg

Do not take Diltiazem Farmalider 300 mg.

• If you are allergic to diltiazem hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If you have any heart rhythm or conduction disorders, such as sick sinus 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 cardiac disease such as left ventricular failure with pulmonary congestion.
• If you are being treated with dantrolene.
• If you are taking medicines containing ivabradine for the treatment of certain heart diseases.
• If you are already taking a medicine containing lomitapide used for the treatment of high cholesterol levels (see section: "Taking Diltiazem Farmalider 300 mg with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diltiazem Farmalider 300 mg.

• If you have heart conditions such as bradycardia (slow heart rate) or first-degree atrioventricular block detected by electrocardiogram, it will be necessary for your doctor to closely monitor you.
• If you are an elderly patient or if you have kidney or liver disease, the concentrations of diltiazem in the blood may be higher, so it will be necessary 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, since diltiazem, like other medicines in the same group, causes a decrease in intestinal movement.
• If you have latent or overt 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 Farmalider 300 mg is not a suitable medicine for children.

Taking Diltiazem Farmalider 300 mg with other medicines

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

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

Certain medicines may interact with Diltiazem Farmalider 300 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 lomitapide used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of lomitapide, which can lead to an increased probability and severity of side effects related to the liver.

It is especially important that you inform your doctor if you are taking any of the following medicines: Medicines for treating heart problems, such as:

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

Since the effects of both can be cumulative, 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, since they produce an increase in 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 can produce a decrease in the amount of diltiazem in the blood, so your doctor will keep you under close surveillance.
• Lithium (medicine for treating mental health problems) since it can increase the toxicity of this. Your doctor will closely monitor your lithium levels in the blood.
• Medicines metabolized by the CYP3A4 enzyme since this can 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 medicines with sedative, anxiolytic, anticonvulsant, amnestic, and muscle relaxant effects. Since diltiazem increases the amounts of these medicines in the blood, which prolongs the time they remain in the body. Your doctor will exercise special caution when prescribing benzodiazepines (especially those with short action) 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 keep you under close surveillance and will need to adjust the dose of methylprednisolone.
• Statins (medicines used to lower cholesterol), since 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 Farmalider 300 mg with food and drinks

The pharmacological effect of Diltiazem Farmalider 300 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 lactation

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.

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 with an alternative method.

Driving and using machines

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

3. How to take Diltiazem Farmalider 300 mg

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will indicate the duration of your treatment with Diltiazem Farmalider 300 mg. Do not stop treatment before.

Remember to take your medicine.

The route of administration of Diltiazem Farmalider 300 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. In general, the recommended doses are as follows:

• Adults: The daily dose, both in angina and hypertension, will be one capsule of Diltiazem Farmalider 300 mg per day, i.e., 300 mg of diltiazem hydrochloride per day.
• Elderly patients: See "Special warnings and precautions for use".

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

If you take more Diltiazem Farmalider 300 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. Take 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you have taken more Diltiazem Farmalider 300 mg than you should, consult your doctor or pharmacist immediately.

A too high dose of Diltiazem Farmalider 300 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 Farmalider 300 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 it is close, 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, Diltiazem Farmalider can cause side effects, although not everybody 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 the 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:malaise

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 (angioedema), 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 formation of pustules or lesions on the skin surface characterized by being small, inflamed, full of pus, and similar to a blister). 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:flushing

Uncommon:low 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:increased levels of liver enzymes in the blood during the initial period of treatment. These elevations are generally transient. Clinical hepatitis (liver disease) that disappears when treatment with diltiazem is discontinued

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

Reproductive system and breast disorders:

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

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

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 that does not appear 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 Farmalider 300 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 expiry date which is stated on the carton, after "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the cartons and medicines you no longer need in the SIGRE collection point at the pharmacy. If you have any further questions, ask your pharmacist how to dispose of the cartons and medicines you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Diltiazem Farmalider 300 mg prolonged-release capsules EFG

• The active ingredient is diltiazem hydrochloride. Each prolonged-release capsule contains 300 mg of diltiazem hydrochloride.
• The other components are: povidone, ethylcellulose, talc, stearic acid. The capsule is composed of: gelatin, titanium dioxide (E-171), indigotine (E-132), quinoline yellow (E-104).

Product Appearance and Container Content

The Diltiazem Farmalider 300 mg capsules are white opaque body and green opaque cap filled with white-whiteish pellets.

They are presented in packs of 28 and clinical packs with 500 prolonged-release capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

FARMALIDER, 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 inMay 2023

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