DILTIWAS RETARD 120 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before taking Diltiwas Retard

Do not take Diltiwas Retard

• if you are allergic to diltiazem hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you have certain heart diseases such as various types of arrhythmia (irregular heartbeats due to sinus node syndrome or second or third degree atrioventricular block, except if you have a pacemaker.
• if you have a very slow pulse of less than 40 beats per minute.
• if you have left ventricular insufficiency (when the left ventricle does not pump the oxygenated blood mass completely to the rest of the body) with fluid accumulation in the lungs.
• if you have congestive heart failure with pulmonary edema (inability of the heart to pump enough blood to the rest of the body and fluid accumulation).
• if you are receiving an intravenous infusion of dantrolene (a muscle relaxant) at the same time.
• if you have hypotension (low blood pressure).
• if you have acute myocardial infarction complicated with very slow pulse, severe hypotension, and left ventricular insufficiency). If you are pregnant or planning to become pregnant.
• if you are a woman of childbearing age and are not using an appropriate contraceptive method.
• if you are breastfeeding.
• if you are taking a medicine that contains ivabradine for the treatment of certain heart diseases.
• if you are already taking a medicine that contains lomitapide used for the treatment of high cholesterol levels (see section: "Taking Diltiwas with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diltiwas Retard

• 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, and your doctor may need to monitor your kidney function.

• If you are an elderly patient.
• If you have any cardiac arrhythmia (sinus node disease, atrioventricular block), if your heart rate is slow, or if you are receiving treatment with other medicines used to treat heart diseases (beta blockers, digitalis) since the use of diltiazem in these situations can lead to an excessively slow pulse and heart rate (bradycardia).
• If you have hypotension: treatment with diltiazem can lead to an excessive drop in blood pressure. Your doctor will inform you about how to avoid the symptoms resulting from hypotension and what measures to take if these symptoms occur.
• If you have any liver or kidney disease or are elderly: since there is no data available in these patients, Diltiwas Retard should be used with caution.
• In children: there is no experience with the use of Diltiwas Retard in children.
• If you develop a skin rash caused by diltiazem, your doctor will assess these symptoms and indicate the measures to take.
• If you require general anesthesia, you should inform the anesthesiologist of the treatment with diltiazem.
• Since the therapeutic effect has not been compared between the different diltiazem specialties with immediate or modified release (retard), it is not recommended to substitute one for another unless explicitly recommended by the prescribing doctor.

Taking Diltiwas Retard with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

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

Medicines that contain 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 liver-related side effects.

Lithium (used for the treatment of certain mental illnesses): risk of increased lithium-induced neurotoxicity.

Nitrate derivatives (to treat hypertension): increase in hypotensive effects and fainting (additive vasodilatory effects). In all patients treated with Diltiwas Retard, the prescription of nitrate derivatives should only be done in gradually increasing doses.

Theophylline (used for asthma): increase in theophylline blood levels.

Alpha-antagonists (to treat hypertension): increase in antihypertensive effects:

Concomitant treatment with alpha-antagonists may produce or worsen hypotension. The combination of diltiazem with an alpha-antagonist should only be considered with strict blood pressure control.

Amiodarone (used to decrease heart rate), digoxin (used to treat heart diseases): increased risk of bradycardia (decrease in heartbeats). Caution should be exercised when these are combined with diltiazem, particularly in elderly subjects and when high doses are used.

Beta-blockers (to treat hypertension): possibility of cardiac alterations.

Other antiarrhythmic agents (used to prevent or suppress cardiac rhythm alterations): since diltiazem has antiarrhythmic properties, its concomitant prescription with other antiarrhythmic agents is not recommended.

Carbamazepine (for the treatment of epilepsy): increase in carbamazepine blood levels.

Rifampicin (antibiotic): risk of decreased diltiazem blood levels after starting treatment with rifampicin.

Agents used to decrease stomach acid (cimetidine, ranitidine): increase in diltiazem blood concentrations.

Cyclosporin (used to suppress the immune system): increase in cyclosporin blood levels.

The combined use of Diltiwas Retard with other medicines should be done under medical control and with gradual dose adjustment.

Due to the possibility of additive effects, caution should be exercised and patients who receive Diltiwas Retard simultaneously with other agents that are known to affect the heart should be carefully evaluated.

Diltiwas Retard is metabolized in the liver by the CYP3A4 isoenzyme, but it also inhibits it. Other medicines have similar or opposite metabolism, and cases of increased blood concentrations of one or both medicines may occur, depending on whether they inhibit or not this liver enzyme.

Benzodiazepines (midazolam, triazolam used to treat anxiety): diltiazem significantly increases midazolam and triazolam blood concentrations.

Corticosteroids (methylprednisolone, used to treat inflammatory problems): diltiazem may increase methylprednisolone blood concentration, and a dose adjustment of methylprednisolone may be necessary.

Statins (medicines to decrease cholesterol levels in blood): diltiazem increases the blood concentration of some statins. There is a risk of myopathy (muscle disorder) and rhabdomyolysis (muscle necrosis with complications such as kidney failure) with the simultaneous use of diltiazem and some statins.

Taking Diltiwas Retard with food, drinks, and alcohol

Diltiwas Retard capsules should be swallowed whole, without chewing, and with a sufficient amount of liquid, preferably before meals.

During treatment with this medicine, you should not drink alcohol, as it may cause a drop in blood pressure with dizziness and/or fainting.

Pregnancy, breastfeeding, and fertility

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.

Do not take Diltiwas Retard if you are pregnant or think you may be pregnant, if you are planning to become pregnant, or if you are breastfeeding.

Women of childbearing age should use an effective contraceptive method. If you become pregnant while taking Diltiwas Retard, stop taking the medicine immediately and consult your doctor. Diltiwas Retard may cause fetal malformations.

Diltiwas Retard is excreted in breast milk, so you should not breastfeed if you are taking this medicine. If the use of this medicine is considered essential, you should use an alternative method for infant feeding.

Driving and using machines

Based on the reported adverse reactions, i.e., dizziness (frequent), general malaise (frequent), the ability to drive and use machines may be impaired. Therefore, it is advisable not to perform tasks that require special attention (driving vehicles, handling hazardous machinery, etc.) until the response to the medicine is satisfactory.

Diltiwas Retard contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Diltiwas Retard

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

Diltiwas Retard is administered orally. Your doctor will indicate how many capsules you should take each day.

Adults:

The dose is 1 capsule every 12 hours. Your doctor will gradually increase the dose until the optimal response is obtained.

Elderly patients, renal or hepatic insufficiency:

The initial dose adjustment should be done with caution.

All dose modifications and their control will be done under medical supervision.

Swallow the capsules whole, without chewing, with a sufficient amount of liquid (e.g., a glass of water). Diltiwas Retard should be taken preferably before meals.

Take Diltiwas Retard every day and approximately at the same time. Taking the capsules at the same time each day will have a better effect on your blood pressure. It will also help you remember when to take the capsules.

Your doctor will indicate the duration of your treatment with Diltiwas Retard. Do not stop the treatment before, as it may be harmful to your health.

If you feel that the effect of Diltiwas Retard is too strong or too weak, consult your doctor or pharmacist.

If you take more Diltiwas Retard than you should

If you take more capsules 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Diltiwas Retard

Do not take a double dose to make up for forgotten doses. It is important that you take Diltiwas Retard regularly at the same time each day. If you forget to take a dose, take it as soon as you can. However, if it is almost time for the next dose, do not take the forgotten capsule.

If you stop taking Diltiwas Retard

If you stop taking Diltiwas Retard, you may have a worsening of your disease, presenting symptoms such as pain or oppression in the chest or a sudden increase in blood pressure. Do not stop taking Diltiwas Retard without consulting your doctor first.

If you have any other questions 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 everybody gets them.

The side effects of diltiazem vary in intensity from one patient to another and should be taken into account especially at the start of treatment or when changing medication.

The following are the frequent side effects (may affect more than 1 in 100 people):

• Redness of the face
• swelling of the legs
• abnormal slowness of the heart rate
• nausea
• headache
• malaise
• dizziness
• intense physical fatigue

The following are the uncommon side effects (may affect up to 1 in 1000 people):

• decrease in blood pressure when standing up
• palpitations
• redness of the skin
• hives with or without fever
• abnormal skin reaction to light

The following are the rare side effects (may affect up to 1 in 10,000 people):

• decreased ability of the heart to pump blood
• digestive disorder
• stomach pain
• constipation
• dry mouth
• moderate elevations of liver transaminases, usually transient
• liver inflammation (hepatitis), usually transient
• generalized skin peeling
• acute pustular eruption
• redness of the skin with peeling
• generalized blistering eruption
• gum swelling
• breast swelling in men, reversible after stopping treatment with diltiazem.

The following are the very rare side effects (may affect up to 1 in more than 10,000 people):

• skin separation and exfoliation due to cell death

The following are the side effects with unknown frequency: cannot be estimated from the available data

• 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").

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Diltiwas Retard

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiry date that appears on the box after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Angileptol mint flavor

Each tablet contains:

• The active ingredients:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

• The other ingredients (excipients) are: sorbitol (E420), acesulfame potassium (E950), magnesium stearate, and mint flavor

Appearance of the product and contents of the pack

Angileptol are sucking tablets, white, round, and with the Greek letter σ on one of the faces.

They come in packs containing 15 and 30 sucking tablets.

Other presentations

Angileptol Mint-eucalyptus flavor

Angileptol Honey-lemon flavor

Marketing authorization holder

Alfasigma Spain S.L.

C/ Aribau 195, 4th floor

08021 Barcelona, Spain

Manufacturer

Pharmaloop, S.L.

Polígono Industrial Azque C/Bolivia, 15

28806 Alcalá de Henares (Madrid), Spain

or

Alfasigma, S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Rome), Italy

Date of the last revision of this leaflet:September 2021

Other sources of information

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